FDA product code OSV: Insufflator, Endoscopic Vessel Harvesting
OSV is the FDA product code for insufflator, endoscopic vessel harvesting. It is a Class II device, regulated under 21 CFR 884.1730 and reviewed by the Obstetrics and Gynecology panel. Devices under OSV reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Endoscopic Vessel Harvesting |
| Device class | Class II |
| Regulation | 21 CFR 884.1730 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for OSV devices
openFDA lists no recalls for product code OSV.
Frequently asked questions
What is FDA product code OSV?
OSV is the FDA product code for insufflator, endoscopic vessel harvesting. It is a Class II device, regulated under 21 CFR 884.1730 and reviewed by the Obstetrics and Gynecology panel.
What device class is OSV?
Class II, regulation 21 CFR 884.1730. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OSV
- Run a recall and safety report across every OSV manufacturer
- Watch product code OSV 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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