The following data is part of a premarket notification filed by Ethicon Endo-surgery Llc with the FDA for Echelon Endopath Staple Line Reinforcement.
| Device ID | K190937 |
| 510k Number | K190937 |
| Device Name: | Echelon Endopath Staple Line Reinforcement |
| Classification | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Applicant | Ethicon Endo-Surgery LLC 475 Calle C Guaynabo, PR 00696 |
| Contact | Emily Nesbitt |
| Correspondent | Emily Nesbitt Ethicon Endo-Surgery LLC 4545 Creek Rd Cincinnati, OH 45242 |
| Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-10 |
| Decision Date | 2019-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036023293 | K190937 | 000 |