K843034 is an FDA 510(k) clearance for the DISPOSABLE LINEAR CUTTER. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on September 17, 1984, 47 days after receiving the submission on August 1, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K843034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1984 |
| Decision Date | September 17, 1984 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |