Cleared Traditional

ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)

K230387 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery

Apr 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K230387 is an FDA 510(k) clearance for the ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on April 13, 2023, 58 days after receiving the submission on February 14, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K230387 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2023
Decision Date	April 13, 2023
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).