K935045 is an FDA 510(k) clearance for the BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on August 19, 1994, 302 days after receiving the submission on October 21, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K935045 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 1993 |
| Decision Date | August 19, 1994 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |