The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon 3000 45mm Stapler, Echelon 3000 60mm Stapler.
| Device ID | K213633 |
| 510k Number | K213633 |
| Device Name: | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler |
| Classification | Stapler, Surgical |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Nathan Anderson |
| Correspondent | Ekta Patel Ethicon Endo-Surgery, LLC 4545 Creek Road Blue Ash, OH 45242 |
| Product Code | GAG |
| CFR Regulation Number | 878.4740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036035012 | K213633 | 000 |
| 20705036035005 | K213633 | 000 |
| 30705036034999 | K213633 | 000 |
| 20705036034985 | K213633 | 000 |
| 30705036034975 | K213633 | 000 |
| 20705036034961 | K213633 | 000 |