The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endocutter 60 Endoscopic Linear Cutter, Models Ec60, Sc60 And Long60 And Endopath & Proximate Linear Cutters.
| Device ID | K061156 |
| 510k Number | K061156 |
| Device Name: | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Tom Morris |
| Correspondent | Tom Morris 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 | 2006-04-26 |
| Decision Date | 2006-07-03 |
| Summary: | summary |