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ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL - Sw232

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992612

by Ethicon Endo-Surgery, Inc.

Identifiers

510(k) Number
K992612 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)
Models / Variants
Sw210 FDA 510(k)
Sw220 FDA 510(k)
Sw220 FDA 510(k)
Sw230 FDA 510(k)
Sw212 FDA 510(k)
Sw222 FDA 510(k)
Sw232 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL - Sw232 by Ethicon Endo-Surgery, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 7 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA 510(k) K992612 24 fields · synced Jun 18, 2026