K010610 is an FDA 510(k) clearance for the RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 27, 2001, 26 days after receiving the submission on March 1, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K010610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2001 |
| Decision Date | March 27, 2001 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC — Endoscope Channel Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |