510(k) K092461 ยท OCX Endoscopic Irrigation/Suction System
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, Nov 5, 2009 |
| Received | Aug 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2015 | US Endoscopy Group Inc Velocity" Biopsy Valve, 25 units per box,
Product Usage:
The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velo Terminated |
OCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.