Medical Device Manufacturer · US , Blue Ash , OH

Ethicon Endo-Surgery, LLC - FDA 510(k) Cleared Devices

71 submissions · 71 cleared · Since 2006

Recent clearances: HARMONIC 1100 Shears (HAR1120), ETHICON™ Circular Stapler (CDH21mm), ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

71
Total
71
Cleared
0
Denied

Ethicon Endo-Surgery, LLC has 71 FDA 510(k) cleared general & plastic surgery devices. Based in Blue Ash, US.

Latest FDA clearance: Sep 2026. Active since 2006.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Ethicon Endo-Surgery, Inc., Ethicon Endo Surgery, Inc. and Ethicon Endo Surgery, LLC. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Ethicon Endo-Surgery, LLC

71 devices
1-12 of 71

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