The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green And Black.
| Device ID | K183435 |
| 510k Number | K183435 |
| Device Name: | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green And Black |
| Classification | Staple, Implantable |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Suite 202 Guaynabo, PR 00969 |
| Contact | Sigfrido Delgado |
| Correspondent | Brian Ruble Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, OH 45245 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-11 |
| Decision Date | 2019-02-06 |
| Summary: | summary |