K903086 is an FDA 510(k) clearance for the TUBE GASTROSTOMY. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by Knight Medical, Inc. (Cambridge, US). The FDA issued a Cleared decision on November 20, 1990, 131 days after receiving the submission on July 12, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K903086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1990 |
| Decision Date | November 20, 1990 |
| Days to Decision | 131 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 |