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FDA 510(k)

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

K-Number: K252906 · 2026-01-09

ApplicantEthicon Endo-Surgery, LLC
Decision Date2026-01-09
Product CodeOXC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2026-01-09 under approval number K252906. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)?

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K252906.

When was ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) approved by the FDA?

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) received FDA 510(k) clearance on 2026-01-09, under approval number K252906.

What company makes ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)?

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)?

The FDA product code for ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) is OXC.

Related Clinical Trials

NCT07339020 Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy COMPLETED

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Related Devices (Code: OXC)

K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc. K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC K221487NEOVEIL Staple Line ReinforcementGunze Limited K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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