K051637 is an FDA 510(k) clearance for the DSNARE, MODEL 00711087. This device is classified as a Instrument, Biopsy, Suction (Class II - Special Controls, product code FCK).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on October 31, 2005, 133 days after receiving the submission on June 20, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K051637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2005 |
| Decision Date | October 31, 2005 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCK - Instrument, Biopsy, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |