510(k) K070420 ยท ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, Mar 19, 2007 |
| Received | Feb 20, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2014 | US Endoscopy Group Inc UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410
The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box.
Used to cover the opening to the bi Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.