The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60mm, Standard, Echelon Flex Powered Plus Articulating.
| Device ID | K140560 |
| 510k Number | K140560 |
| Device Name: | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Asifa Vonhof |
| Correspondent | Asifa Vonhof ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-04-22 |
| Summary: | summary |