K071066 is an FDA 510(k) clearance for the SPYCATCH STONE RETRIEVAL BASKET. This device is classified as a Dislodger, Stone, Biliary (Class II - Special Controls, product code LQR).
Submitted by Boston Scientific Corp (Marlborough, US). The FDA issued a Cleared decision on June 29, 2007, 74 days after receiving the submission on April 16, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K071066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2007 |
| Decision Date | June 29, 2007 |
| Days to Decision | 74 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQR — Dislodger, Stone, Biliary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |