The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal X1 Tissue Sealer, Straight Jaw, 25 Cm Shaft Length, Enseal X1 Tissue Sealer, Straight Jaw, 37 Cm Shaft Length.
| Device ID | K201696 |
| 510k Number | K201696 |
| Device Name: | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 Cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 Cm Shaft Length |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00696 |
| Contact | Nathan Anderson |
| Correspondent | Kweku Biney Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2021-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036015489 | K201696 | 000 |
| 20705036015458 | K201696 | 000 |