K910492 is an FDA 510(k) clearance for the BARD REPLACEMENT GASTROSTOMY TUBE. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on July 24, 1991, 169 days after receiving the submission on February 5, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K910492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1991 |
| Decision Date | July 24, 1991 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KGC — Tube, Gastro-enterostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |