The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Curved Cutter Stapler, Models Cs40b, Cs40g; Reload For Curved Stapler, Models Cr40b, Cr40g.
| Device ID | K040038 |
| 510k Number | K040038 |
| Device Name: | CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Katie Fordyce |
| Correspondent | Katie Fordyce ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-08 |
| Decision Date | 2004-02-04 |
| Summary: | summary |