FDA product code OCK: Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
OCK is the FDA product code for transurethral occlusion insert, urinary incontinence-control, female. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under OCK reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 8 recalls for OCK devices.
Definition
Transurethral insert for urinary occlusion/control in women with urinary incontinence
Classification
| Field | Value |
|---|---|
| Device name | Transurethral Occlusion Insert, Urinary Incontinence-Control, Female |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OCK devices
8 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-04-27.
Frequently asked questions
What is FDA product code OCK?
OCK is the FDA product code for transurethral occlusion insert, urinary incontinence-control, female. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is OCK?
Class III. Typical premarket route: PMA.
Have OCK devices been recalled?
Yes: 8 product recalls across 1 recall events; the most recent began 2010-04-27.
Next steps
- Run an FDA pathway report with predicate devices for product code OCK
- Run a recall and safety report across every OCK manufacturer
- Watch product code OCK 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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