K101657 is an FDA 510(k) clearance for the RADIAL 4 HOT BIOPSY FORCEPS BOX 5. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on October 5, 2010, 116 days after receiving the submission on June 11, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K101657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2010 |
| Decision Date | October 05, 2010 |
| Days to Decision | 116 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE — Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |