FDA product code OCQ: Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence
OCQ is the FDA product code for laparoscopic bladder-neck suspension instrument, stress urinary incontinence. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Gastroenterology and Urology panel. Devices under OCQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For female urinary stress incontinence due to hypermobility
Classification
| Field | Value |
|---|---|
| Device name | Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence |
| Device class | Class II |
| Regulation | 21 CFR 884.1720 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for OCQ devices
openFDA lists no recalls for product code OCQ.
Frequently asked questions
What is FDA product code OCQ?
OCQ is the FDA product code for laparoscopic bladder-neck suspension instrument, stress urinary incontinence. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Gastroenterology and Urology panel.
What device class is OCQ?
Class II, regulation 21 CFR 884.1720. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OCQ
- Run a recall and safety report across every OCQ manufacturer
- Watch product code OCQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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