K915837 is an FDA 510(k) clearance for the NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on March 23, 1993, 455 days after receiving the submission on December 24, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K915837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 24, 1991 |
| Decision Date | March 23, 1993 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |