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 Endopath Endoscopic Linear Cutter Reloads, 45mm.
| Device ID | K163454 |
| 510k Number | K163454 |
| Device Name: | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 475 CALLE C Guaynabo, PR 00969 |
| Contact | Carmen Ortiz |
| Correspondent | Asifa Vonhof ETHICON ENDO SURGERY, INC. 4545 CREEK ROAD Cincinnati, 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 | 2016-12-09 |
| Decision Date | 2017-01-05 |
| Summary: | summary |