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 | K221343 |
| 510k Number | K221343 |
| 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 | Rubina Dosani |
| Correspondent | Rubina Dosani Ethicon Endo-Surgery LLC 475 Calle C Guaynabo, PR 00696 |
| Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-09 |
| Decision Date | 2022-09-16 |