876.5100 Suprapubic catheter accessories.§ 876.5100 Suprapubic catheter accessories.
(a) Identification. Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.[84 FR 14870, Apr. 12, 2019]