K864963 is an FDA 510(k) clearance for the STOMACH EVACULATOR - EWALD STYLE. This device is classified as a Surgical Instruments, G-u, Manual (and Accessories) (Class I - General Controls, product code KOA).
Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 14, 1987, 296 days after receiving the submission on December 22, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K864963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1986 |
| Decision Date | October 14, 1987 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOA — Surgical Instruments, G-u, Manual (and Accessories) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |