The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endocutter Gray Cartridge, Model 6r45m/gray Cartridge Reload.
| Device ID | K033269 |
| 510k Number | K033269 |
| Device Name: | ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Georgia C Abernathy |
| Correspondent | Georgia C Abernathy ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-09 |
| Decision Date | 2003-12-10 |
| Summary: | summary |