21 CFR § 876.5290 - Implanted mechanical/hydraulic urinary continence device surgical accessories.

---
identifier: "/us/cfr/t21/s876.5290"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.5290 - Implanted mechanical/hydraulic urinary continence device surgical accessories."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.5290"
section_name: "Implanted mechanical/hydraulic urinary continence device surgical accessories."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.

(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.

[84 FR 14870, Apr. 12, 2019]