K913678 is an FDA 510(k) clearance for the TROCAR CATHETER. This device is classified as a Bag, Intestine (Class I - General Controls, product code KGY).
Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 16, 1991, 119 days after receiving the submission on August 19, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4100.
| 510(k) Number | K913678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1991 |
| Decision Date | December 16, 1991 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGY — Bag, Intestine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4100 |