K042897 is an FDA 510(k) clearance for the AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 19, 2004, 30 days after receiving the submission on October 20, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K042897 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2004 |
| Decision Date | November 19, 2004 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAL — Suture, Absorbable, Natural |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4830 |