The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Ez45 Endoscopic Linear Cutter.
| Device ID | K980815 |
| 510k Number | K980815 |
| Device Name: | ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Lorri Chavez |
| Correspondent | Lorri Chavez 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 | 1998-03-03 |
| Decision Date | 1998-05-01 |
| Summary: | summary |