← Back to catalogue

ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230387

by Ethicon Endo-Surgery, LLC

Identifiers

510(k) Number
K230387 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
Models / Variants
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) FDA 510(k)
ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C) FDA 510(k)
ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C) FDA 510(k)
ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S) FDA 510(k)
ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) +4 more models by Ethicon Endo-Surgery, LLC — Class II — FDA_510K — listed in FDA 510(k) — 5…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC

Sources (1)

  • FDA 510(k) K230387 24 fields · synced Jun 18, 2026