K954599 is an FDA 510(k) clearance for the CONMED TROGARD ELECTRONIC TROCAR SYSTEM, a Cannula, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEA), submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on November 27, 1995, 55 days after receiving the submission on October 3, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K954599 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 1995 |
| Decision Date | November 27, 1995 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEA — Cannula, Surgical, General & Plastic Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |