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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 the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2026-01-09 under 510(k) 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. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K252906.

When did ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) receive FDA 510(k) clearance?

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

Who is the listed applicant for ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07744568A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic ProceduresNOT_YET_RECRUITINGNCT04253392RETHINK REFLUX RegistryACTIVE_NOT_RECRUITINGNCT06608485A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical ProceduresCOMPLETEDNCT07339020Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve GastrectomyCOMPLETED

Other records listing Ethicon Endo-Surgery, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

View all 36 devices →

Related Devices (Code: OXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLCK221487NEOVEIL Staple Line ReinforcementGunze LimitedK190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLCK181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, 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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