K884709 is an FDA 510(k) clearance for the ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL). This device is classified as a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II - Special Controls, product code ODD).
Submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on September 8, 1989, 304 days after receiving the submission on November 8, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Identify Stones, Tumors, Or Narrowing In The Biliary Tree..
| 510(k) Number | K884709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1988 |
| Decision Date | September 08, 1989 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | ODD — Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Identify Stones, Tumors, Or Narrowing In The Biliary Tree. |