K920110 is an FDA 510(k) clearance for the ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE. This device is classified as a Cannula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEA).
Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 2, 1992, 86 days after receiving the submission on January 7, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K920110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1992 |
| Decision Date | April 02, 1992 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEA — Cannula, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |