510(k) Report

FDA product code · Gastroenterology and urology

Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence

OCQClass II21 CFR 884.1720510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

For female urinary stress incontinence due to hypermobility

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of OCQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — OCQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OCQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 884.1720.