The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Ets45, Ets Flex45, Ets Compact-flex45 Linear Cutters, Ets Flex45 And Ets Compact-flex45 No-knife Articulating.
| Device ID | K002398 |
| 510k Number | K002398 |
| Device Name: | ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Edwin O Billips |
| Correspondent | Edwin O Billips ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-11-03 |
| Summary: | summary |