';
Toggle navigation
eCFR
Home
Title 21
PART 878 SUBPART E
CFR
›
Title 21
›
Volume 8
›
Chapter I
›
Subchapter H
›
Part 878
›
Subpart E
Subpart E - Surgical Devices
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
53 FR 23872, June 24, 1988, unless otherwise noted.
21:8.0.1.1.26.5.1.1
SECTION 878.4010
878.4010 Tissue adhesive.
21:8.0.1.1.26.5.1.2
SECTION 878.4011
878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
21:8.0.1.1.26.5.1.3
SECTION 878.4014
878.4014 Nonresorbable gauze/sponge for external use.
21:8.0.1.1.26.5.1.4
SECTION 878.4015
878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
21:8.0.1.1.26.5.1.5
SECTION 878.4018
878.4018 Hydrophilic wound dressing.
21:8.0.1.1.26.5.1.6
SECTION 878.4020
878.4020 Occlusive wound dressing.
21:8.0.1.1.26.5.1.7
SECTION 878.4022
878.4022 Hydrogel wound dressing and burn dressing.
21:8.0.1.1.26.5.1.8
SECTION 878.4025
878.4025 Silicone sheeting.
21:8.0.1.1.26.5.1.9
SECTION 878.4040
878.4040 Surgical apparel.
21:8.0.1.1.26.5.1.10
SECTION 878.4100
878.4100 Organ bag.
21:8.0.1.1.26.5.1.11
SECTION 878.4160
878.4160 Surgical camera and accessories.
21:8.0.1.1.26.5.1.12
SECTION 878.4165
878.4165 Wound autofluorescence imaging device.
21:8.0.1.1.26.5.1.13
SECTION 878.4200
878.4200 Introduction/drainage catheter and accessories.
21:8.0.1.1.26.5.1.14
SECTION 878.4300
878.4300 Implantable clip.
21:8.0.1.1.26.5.1.15
SECTION 878.4320
878.4320 Removable skin clip.
21:8.0.1.1.26.5.1.16
SECTION 878.4340
878.4340 Contact cooling system for aesthetic use.
21:8.0.1.1.26.5.1.17
SECTION 878.4350
878.4350 Cryosurgical unit and accessories.
21:8.0.1.1.26.5.1.18
SECTION 878.4360
878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
21:8.0.1.1.26.5.1.19
SECTION 878.4370
878.4370 Surgical drape and drape accessories.
21:8.0.1.1.26.5.1.20
SECTION 878.4371
878.4371 Irrigating wound retractor device.
21:8.0.1.1.26.5.1.21
SECTION 878.4380
878.4380 Drape adhesive.
21:8.0.1.1.26.5.1.22
SECTION 878.4400
878.4400 Electrosurgical cutting and coagulation device and accessories.
21:8.0.1.1.26.5.1.23
SECTION 878.4410
878.4410 Low energy ultrasound wound cleaner.
21:8.0.1.1.26.5.1.24
SECTION 878.4420
878.4420 Electrosurgical device for over-the-counter aesthetic use.
21:8.0.1.1.26.5.1.25
SECTION 878.4430
878.4430 Microneedling device for aesthetic use.
21:8.0.1.1.26.5.1.26
SECTION 878.4440
878.4440 Eye pad.
21:8.0.1.1.26.5.1.27
SECTION 878.4450
878.4450 Nonabsorbable gauze for internal use.
21:8.0.1.1.26.5.1.28
SECTION 878.4452
878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
21:8.0.1.1.26.5.1.29
SECTION 878.4454
878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
21:8.0.1.1.26.5.1.30
SECTION 878.4456
878.4456 Hemostatic device for intraluminal gastrointestinal use.
21:8.0.1.1.26.5.1.31
SECTION 878.4460
878.4460 Non-powdered surgeon's glove.
21:8.0.1.1.26.5.1.32
SECTION 878.4470
878.4470 Surgeon's gloving cream.
21:8.0.1.1.26.5.1.33
SECTION 878.4490
878.4490 Absorbable hemostatic agent and dressing.
21:8.0.1.1.26.5.1.34
SECTION 878.4493
878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
21:8.0.1.1.26.5.1.35
SECTION 878.4494
878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
21:8.0.1.1.26.5.1.36
SECTION 878.4495
878.4495 Stainless steel suture.
21:8.0.1.1.26.5.1.37
SECTION 878.4520
878.4520 Polytetrafluoroethylene injectable.
21:8.0.1.1.26.5.1.38
SECTION 878.4580
878.4580 Surgical lamp.
21:8.0.1.1.26.5.1.39
SECTION 878.4590
878.4590 Focused ultrasound stimulator system for aesthetic use.
21:8.0.1.1.26.5.1.40
SECTION 878.4630
878.4630 Ultraviolet lamp for dermatologic disorders.
21:8.0.1.1.26.5.1.41
SECTION 878.4635
878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
21:8.0.1.1.26.5.1.42
SECTION 878.4660
878.4660 Skin marker.
21:8.0.1.1.26.5.1.43
SECTION 878.4670
878.4670 Internal tissue marker.
21:8.0.1.1.26.5.1.44
SECTION 878.4680
878.4680 Nonpowered, single patient, portable suction apparatus.
21:8.0.1.1.26.5.1.45
SECTION 878.4683
878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
21:8.0.1.1.26.5.1.46
SECTION 878.4685
878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
21:8.0.1.1.26.5.1.47
SECTION 878.4700
878.4700 Surgical microscope and accessories.
21:8.0.1.1.26.5.1.48
SECTION 878.4730
878.4730 Surgical skin degreaser or adhesive tape solvent.
21:8.0.1.1.26.5.1.49
SECTION 878.4750
878.4750 Implantable staple.
21:8.0.1.1.26.5.1.50
SECTION 878.4755
878.4755 Absorbable lung biopsy plug.
21:8.0.1.1.26.5.1.51
SECTION 878.4760
878.4760 Removable skin staple.
21:8.0.1.1.26.5.1.52
SECTION 878.4780
878.4780 Powered suction pump.
21:8.0.1.1.26.5.1.53
SECTION 878.4790
878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
21:8.0.1.1.26.5.1.54
SECTION 878.4800
878.4800 Manual surgical instrument for general use.
21:8.0.1.1.26.5.1.55
SECTION 878.4810
878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
21:8.0.1.1.26.5.1.56
SECTION 878.4815
878.4815 Magnetic surgical instrument system.
21:8.0.1.1.26.5.1.57
SECTION 878.4820
878.4820 Surgical instrument motors and accessories/attachments.
21:8.0.1.1.26.5.1.58
SECTION 878.4830
878.4830 Absorbable surgical gut suture.
21:8.0.1.1.26.5.1.59
SECTION 878.4840
878.4840 Absorbable polydioxanone surgical suture.
21:8.0.1.1.26.5.1.60
SECTION 878.4860
878.4860 Light based energy source device for topical application.
21:8.0.1.1.26.5.1.61
SECTION 878.4930
878.4930 Suture retention device.
21:8.0.1.1.26.5.1.62
SECTION 878.4950
878.4950 Manual operating table and accessories and manual operating chair and accessories.
21:8.0.1.1.26.5.1.63
SECTION 878.4960
878.4960 Operating tables and accessories and operating chairs and accessories.
21:8.0.1.1.26.5.1.64
SECTION 878.5000
878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
21:8.0.1.1.26.5.1.65
SECTION 878.5010
878.5010 Nonabsorbable polypropylene surgical suture.
21:8.0.1.1.26.5.1.66
SECTION 878.5020
878.5020 Nonabsorbable polyamide surgical suture.
21:8.0.1.1.26.5.1.67
SECTION 878.5030
878.5030 Natural nonabsorbable silk surgical suture.
21:8.0.1.1.26.5.1.68
SECTION 878.5035
878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
21:8.0.1.1.26.5.1.69
SECTION 878.5040
878.5040 Suction lipoplasty system.
21:8.0.1.1.26.5.1.70
SECTION 878.5050
878.5050 Surgical smoke precipitator.