The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Echelon Flex Powered Vascular Stapler With Advanced Placement Tip, Endopath Echelon Vascular White Reloads For Advanced.
| Device ID | K141952 |
| 510k Number | K141952 |
| Device Name: | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Linda Hill |
| Correspondent | Linda Hill ETHICON ENDO-SURGERY, INC. 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 | 2014-07-18 |
| Decision Date | 2014-11-24 |
| Summary: | summary |