K103326 is an FDA 510(k) clearance for the MULTIPLE BIOPSY SYSTEM. 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 April 6, 2011, 145 days after receiving the submission on November 12, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K103326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2010 |
| Decision Date | April 06, 2011 |
| Days to Decision | 145 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 |