Title 21

PART 884

Part 884 - Obstetrical And Gynecological Devices

PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:45 FR 12684, Feb. 26, 1980, unless otherwise noted.

21:8.0.1.1.29.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.29.1.1.1SECTION 884.1
   884.1 Scope.
21:8.0.1.1.29.1.1.2SECTION 884.3
   884.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.29.1.1.3SECTION 884.9
   884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.29.2SUBPART B
Subpart B - Obstetrical and Gynecological Diagnostic Devices
21:8.0.1.1.29.2.1.1SECTION 884.1040
   884.1040 Viscometer for cervical mucus.
21:8.0.1.1.29.2.1.2SECTION 884.1050
   884.1050 Endocervical aspirator.
21:8.0.1.1.29.2.1.3SECTION 884.1060
   884.1060 Endometrial aspirator.
21:8.0.1.1.29.2.1.4SECTION 884.1100
   884.1100 Endometrial brush.
21:8.0.1.1.29.2.1.5SECTION 884.1175
   884.1175 Endometrial suction curette and accessories.
21:8.0.1.1.29.2.1.6SECTION 884.1185
   884.1185 Endometrial washer.
21:8.0.1.1.29.2.1.7SECTION 884.1300
   884.1300 Uterotubal carbon dioxide insufflator and accessories.
21:8.0.1.1.29.2.1.8SECTION 884.1425
   884.1425 Perineometer.
21:8.0.1.1.29.2.1.9SECTION 884.1550
   884.1550 Amniotic fluid sampler (amniocentesis tray).
21:8.0.1.1.29.2.1.10SECTION 884.1560
   884.1560 Fetal blood sampler.
21:8.0.1.1.29.2.1.11SECTION 884.1600
   884.1600 Transabdominal amnioscope (fetoscope) and accessories.
21:8.0.1.1.29.2.1.12SECTION 884.1630
   884.1630 Colposcope.
21:8.0.1.1.29.2.1.13SECTION 884.1640
   884.1640 Culdoscope and accessories.
21:8.0.1.1.29.2.1.14SECTION 884.1660
   884.1660 Transcervical endoscope (amnioscope) and accessories.
21:8.0.1.1.29.2.1.15SECTION 884.1690
   884.1690 Hysteroscope and accessories.
21:8.0.1.1.29.2.1.16SECTION 884.1700
   884.1700 Hysteroscopic insufflator.
21:8.0.1.1.29.2.1.17SECTION 884.1710
   884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
21:8.0.1.1.29.2.1.18SECTION 884.1720
   884.1720 Gynecologic laparoscope and accessories.
21:8.0.1.1.29.2.1.19SECTION 884.1730
   884.1730 Laparoscopic insufflator.
21:8.0.1.1.29.3SUBPART C
Subpart C - Obstetrical and Gynecological Monitoring Devices
21:8.0.1.1.29.3.1.1SECTION 884.2050
   884.2050 Obstetric data analyzer.
21:8.0.1.1.29.3.1.2SECTION 884.2225
   884.2225 Obstetric-gynecologic ultrasonic imager.
21:8.0.1.1.29.3.1.3SECTION 884.2600
   884.2600 Fetal cardiac monitor.
21:8.0.1.1.29.3.1.4SECTION 884.2620
   884.2620 Fetal electroencephalographic monitor.
21:8.0.1.1.29.3.1.5SECTION 884.2640
   884.2640 Fetal phonocardiographic monitor and accessories.
21:8.0.1.1.29.3.1.6SECTION 884.2660
   884.2660 Fetal ultrasonic monitor and accessories.
21:8.0.1.1.29.3.1.7SECTION 884.2675
   884.2675 Fetal scalp circular (spiral) electrode and applicator.
21:8.0.1.1.29.3.1.8SECTION 884.2685
   884.2685 Fetal scalp clip electrode and applicator.
21:8.0.1.1.29.3.1.9SECTION 884.2700
   884.2700 Intrauterine pressure monitor and accessories.
21:8.0.1.1.29.3.1.10SECTION 884.2720
   884.2720 External uterine contraction monitor and accessories.
21:8.0.1.1.29.3.1.11SECTION 884.2730
   884.2730 Home uterine activity monitor.
21:8.0.1.1.29.3.1.12SECTION 884.2740
   884.2740 Perinatal monitoring system and accessories.
21:8.0.1.1.29.3.1.13SECTION 884.2800
   884.2800 Computerized Labor Monitoring System.
21:8.0.1.1.29.3.1.14SECTION 884.2900
   884.2900 Fetal stethoscope.
21:8.0.1.1.29.3.1.15SECTION 884.2960
   884.2960 Obstetric ultrasonic transducer and accessories.
21:8.0.1.1.29.3.1.16SECTION 884.2980
   884.2980 Telethermographic system.
21:8.0.1.1.29.3.1.17SECTION 884.2982
   884.2982 Liquid crystal thermographic system.
21:8.0.1.1.29.3.1.18SECTION 884.2990
   884.2990 Breast lesion documentation system.
21:8.0.1.1.29.4SUBPART D
Subpart D - Obstetrical and Gynecological Prosthetic Devices
21:8.0.1.1.29.4.1.1SECTION 884.3200
   884.3200 Cervical drain.
21:8.0.1.1.29.4.1.2SECTION 884.3575
   884.3575 Vaginal pessary.
21:8.0.1.1.29.4.1.3SECTION 884.3650
   884.3650 Fallopian tube prosthesis.
21:8.0.1.1.29.4.1.4SECTION 884.3900
   884.3900 Vaginal stent.
21:8.0.1.1.29.5SUBPART E
Subpart E - Obstetrical and Gynecological Surgical Devices
21:8.0.1.1.29.5.1.1SECTION 884.4050
   884.4050 Gynecologic laparoscopic power morcellation containment system.
21:8.0.1.1.29.5.1.2SECTION 884.4100
   884.4100 Endoscopic electrocautery and accessories.
21:8.0.1.1.29.5.1.3SECTION 884.4120
   884.4120 Gynecologic electrocautery and accessories.
21:8.0.1.1.29.5.1.4SECTION 884.4150
   884.4150 Bipolar endoscopic coagulator-cutter and accessories.
21:8.0.1.1.29.5.1.5SECTION 884.4160
   884.4160 Unipolar endoscopic coagulator-cutter and accessories.
21:8.0.1.1.29.5.1.6SECTION 884.4250
   884.4250 Expandable cervical dilator.
21:8.0.1.1.29.5.1.7SECTION 884.4260
   884.4260 Hygroscopic Laminaria cervical dilator.
21:8.0.1.1.29.5.1.8SECTION 884.4270
   884.4270 Vibratory cervical dilators.
21:8.0.1.1.29.5.1.9SECTION 884.4340
   884.4340 Fetal vacuum extractor.
21:8.0.1.1.29.5.1.10SECTION 884.4350
   884.4350 Fetal head elevator.
21:8.0.1.1.29.5.1.11SECTION 884.4400
   884.4400 Obstetric forceps.
21:8.0.1.1.29.5.1.12SECTION 884.4500
   884.4500 Obstetric fetal destructive instrument.
21:8.0.1.1.29.5.1.13SECTION 884.4520
   884.4520 Obstetric-gynecologic general manual instrument.
21:8.0.1.1.29.5.1.14SECTION 884.4530
   884.4530 Obstetric-gynecologic specialized manual instrument.
21:8.0.1.1.29.5.1.15SECTION 884.4550
   884.4550 Gynecologic surgical laser.
21:8.0.1.1.29.5.1.16SECTION 884.4900
   884.4900 Obstetric table and accessories.
21:8.0.1.1.29.5.1.17SECTION 884.4910
   884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
21:8.0.1.1.29.6SUBPART F
Subpart F - Obstetrical and Gynecological Therapeutic Devices
21:8.0.1.1.29.6.1.1SECTION 884.5050
   884.5050 Metreurynter-balloon abortion system.
21:8.0.1.1.29.6.1.2SECTION 884.5070
   884.5070 Vacuum abortion system.
21:8.0.1.1.29.6.1.3SECTION 884.5100
   884.5100 Obstetric anesthesia set.
21:8.0.1.1.29.6.1.4SECTION 884.5150
   884.5150 Nonpowered breast pump.
21:8.0.1.1.29.6.1.5SECTION 884.5160
   884.5160 Powered breast pump.
21:8.0.1.1.29.6.1.6SECTION 884.5200
   884.5200 Hemorrhoid prevention pressure wedge.
21:8.0.1.1.29.6.1.7SECTION 884.5210
   884.5210 Pressure wedge for the reduction of cesarean delivery.
21:8.0.1.1.29.6.1.8SECTION 884.5225
   884.5225 Abdominal decompression chamber.
21:8.0.1.1.29.6.1.9SECTION 884.5250
   884.5250 Cervical cap.
21:8.0.1.1.29.6.1.10SECTION 884.5300
   884.5300 Condom.
21:8.0.1.1.29.6.1.11SECTION 884.5310
   884.5310 Condom with spermicidal lubricant.
21:8.0.1.1.29.6.1.12SECTION 884.5320
   884.5320 Glans sheath.
21:8.0.1.1.29.6.1.13SECTION 884.5330
   884.5330 Multiple-use female condom.
21:8.0.1.1.29.6.1.14SECTION 884.5340
   884.5340 Single-use internal condom.
21:8.0.1.1.29.6.1.15SECTION 884.5350
   884.5350 Contraceptive diaphragm and accessories.
21:8.0.1.1.29.6.1.16SECTION 884.5360
   884.5360 Contraceptive intrauterine device (IUD) and introducer.
21:8.0.1.1.29.6.1.17SECTION 884.5370
   884.5370 Software application for contraception.
21:8.0.1.1.29.6.1.18SECTION 884.5380
   884.5380 Contraceptive tubal occlusion device (TOD) and introducer.
21:8.0.1.1.29.6.1.19SECTION 884.5390
   884.5390 Perineal heater.
21:8.0.1.1.29.6.1.20SECTION 884.5400
   884.5400 Menstrual cup.
21:8.0.1.1.29.6.1.21SECTION 884.5425
   884.5425 Scented or scented deodorized menstrual pad.
21:8.0.1.1.29.6.1.22SECTION 884.5435
   884.5435 Unscented menstrual pad.
21:8.0.1.1.29.6.1.23SECTION 884.5460
   884.5460 Scented or scented deodorized menstrual tampon.
21:8.0.1.1.29.6.1.24SECTION 884.5470
   884.5470 Unscented menstrual tampon.
21:8.0.1.1.29.6.1.25SECTION 884.5900
   884.5900 Therapeutic vaginal douche apparatus.
21:8.0.1.1.29.6.1.26SECTION 884.5920
   884.5920 Vaginal insufflator.
21:8.0.1.1.29.6.1.27SECTION 884.5940
   884.5940 Powered vaginal muscle stimulator for therapeutic use.
21:8.0.1.1.29.6.1.28SECTION 884.5960
   884.5960 Genital vibrator for therapeutic use.
21:8.0.1.1.29.6.1.29SECTION 884.5970
   884.5970 Clitoral engorgement device.
21:8.0.1.1.29.6.1.30SECTION 884.5980
   884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
21:8.0.1.1.29.7SUBPART G
Subpart G - Assisted Reproduction Devices
21:8.0.1.1.29.7.1.1SECTION 884.6100
   884.6100 Assisted reproduction needles.
21:8.0.1.1.29.7.1.2SECTION 884.6110
   884.6110 Assisted reproduction catheters.
21:8.0.1.1.29.7.1.3SECTION 884.6120
   884.6120 Assisted reproduction accessories.
21:8.0.1.1.29.7.1.4SECTION 884.6130
   884.6130 Assisted reproduction microtools.
21:8.0.1.1.29.7.1.5SECTION 884.6140
   884.6140 Assisted reproduction micropipette fabrication instruments.
21:8.0.1.1.29.7.1.6SECTION 884.6150
   884.6150 Assisted reproduction micromanipulators and microinjectors.
21:8.0.1.1.29.7.1.7SECTION 884.6160
   884.6160 Assisted reproduction labware.
21:8.0.1.1.29.7.1.8SECTION 884.6165
   884.6165 Intravaginal culture system.
21:8.0.1.1.29.7.1.9SECTION 884.6170
   884.6170 Assisted reproduction water and water purification systems.
21:8.0.1.1.29.7.1.10SECTION 884.6180
   884.6180 Reproductive media and supplements.
21:8.0.1.1.29.7.1.11SECTION 884.6190
   884.6190 Assisted reproductive microscopes and microscope accessories.
21:8.0.1.1.29.7.1.12SECTION 884.6195
   884.6195 Assisted Reproduction Embryo Image Assessment System.
21:8.0.1.1.29.7.1.13SECTION 884.6200
   884.6200 Assisted reproduction laser system.