K843187 is an FDA 510(k) clearance for the CANNULA. This device is classified as a Cannula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEA).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on October 31, 1984, 79 days after receiving the submission on August 13, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K843187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1984 |
| Decision Date | October 31, 1984 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEA — Cannula, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |