The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Autobahn Tissue Closure Device And Disposable Cartridge.
| Device ID | K042897 |
| 510k Number | K042897 |
| Device Name: | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE |
| Classification | Suture, Absorbable, Natural |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Elizabeth Miller |
| Correspondent | Elizabeth Miller ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GAL |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAQ |
| Subsequent Product Code | GDF |
| Subsequent Product Code | NBY |
| Subsequent Product Code | NJU |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-20 |
| Decision Date | 2004-11-19 |
| Summary: | summary |