K930022 is an FDA 510(k) clearance for the SPHINCTEROTOME. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on April 27, 1993, 112 days after receiving the submission on January 5, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K930022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1993 |
| Decision Date | April 27, 1993 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |