The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, .
| Device ID | K202665 |
| 510k Number | K202665 |
| Device Name: | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, |
| Classification | Staple, Implantable |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Nathan Anderson |
| Correspondent | Ekta Patel Ethicon Endo-Surgery, LLC 4545 Creek Road Blue Ash, OH 45242 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2020-10-15 |