21 CFR 876.5290
§ 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.5290, § 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90337
- Permanent ID
ys:prov:90337@1- SHA-256
86d8ab6d81570a7a102696ab67f346f5ed7e537de47aed3d8216416cfe852702
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.