Code of Federal Regulations (Last Updated: April 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 876 - Gastroenterology-Urology Devices |
Subpart F - Therapeutic Devices |
§ 876.5100 - xxx
Latest version.
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§ 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. CITA>
[84 FR 14870, Apr. 12, 2019]