The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Endopath Ets 35mm Endoscopic Linear Cutter And Reloads, And Ets-flex 35mm Endoscopic Articulating Linear Cutter And Relo.
| Device ID | K111111 |
| 510k Number | K111111 |
| Device Name: | ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Linda Hill |
| Correspondent | Linda Hill 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 | 2011-04-20 |
| Decision Date | 2011-06-08 |
| Summary: | summary |