ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)— 510(k) K252906

Name: FDA 510(k) clearance K252906
Creator: U.S. Food and Drug Administration
Published: 2026-01-09

Substantially Equivalent

Ethicon Endo-Surgery, LLC

FDA 510(k) clearance K252906 for ECHELON ENDOPATH Staple Line Reinforcement (ECH60R), Substantially Equivalent on 2026-01-09. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.

Clearance details

Applicant: Ethicon Endo-Surgery, LLC
Product code: Code OXC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-09-12
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guaynabo, PR, US

Download summary PDF View on FDA.gov ↗

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K190937 — Echelon Endopath Staple Line Reinforcement2019-10-14
K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement2018-08-17

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