The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Endopath Ets-flex45 Endoscopic Articulating Linear Cutter, Endopath Ets-flex45 No-knife Articulating Linear Stapler.
| Device ID | K150026 |
| 510k Number | K150026 |
| Device Name: | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 475 CALLE C Guaynabo, PR 00969 |
| Contact | Marjorie Medina |
| Correspondent | Christina Canter ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-07 |
| Decision Date | 2015-05-18 |
| Summary: | summary |