ECHELON ENDOPATH Staple Line Reinforcement— 510(k) K221343

Name: FDA 510(k) clearance K221343
Creator: U.S. Food and Drug Administration
Published: 2022-09-16

Substantially Equivalent

Ethicon Endo-Surgery, LLC

FDA 510(k) clearance K221343 for ECHELON ENDOPATH Staple Line Reinforcement, Substantially Equivalent on 2022-09-16. 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: 2022-05-09
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guaynabo, PR, US

Download summary PDF View on FDA.gov ↗

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K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement2018-08-17

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