K962676 is an FDA 510(k) clearance for the DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE. This device is classified as a Dislodger, Stone, Flexible (Class II - Special Controls, product code FGO).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on October 4, 1996, 87 days after receiving the submission on July 9, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K962676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 1996 |
| Decision Date | October 04, 1996 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGO - Dislodger, Stone, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |