The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; Enseal X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length.
Device ID | K180403 |
510k Number | K180403 |
Device Name: | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
Contact | Sigfrido Delgado |
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 | 2018-02-14 |
Decision Date | 2018-05-23 |
Summary: | summary |