Ethicon Endo-Surgery, LLC - FDA 510(k) Cleared Devices
Recent clearances: HARMONIC 1100 Shears (HAR1120), ETHICON™ Circular Stapler (CDH21mm), ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
71
Total
71
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ethicon Endo-Surgery, LLC General & Plastic Surgery ✕
69 devices
Cleared
Sep 17, 2026
HARMONIC 1100 Shears (HAR1120)
General & Plastic Surgery
268d
Cleared
May 11, 2026
ETHICON™ Circular Stapler (CDH21mm)
General & Plastic Surgery
109d
Cleared
Jan 09, 2026
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
General & Plastic Surgery
119d
Cleared
Dec 17, 2025
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
General & Plastic Surgery
111d
Cleared
May 14, 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
General & Plastic Surgery
55d
Cleared
Feb 25, 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
General & Plastic Surgery
132d
Cleared
Oct 28, 2024
ECHELON 4000 60mm Compact Stapler (EC3D60C)
General & Plastic Surgery
144d
Cleared
Jul 03, 2024
ECHELON 3000 45mm Compact Stapler (ECH45C)
General & Plastic Surgery
27d
Cleared
Aug 29, 2023
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420)
General & Plastic Surgery
27d
Cleared
Apr 13, 2023
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C)
General & Plastic Surgery
58d
Cleared
Feb 28, 2023
HARMONIC 700 Shears
General & Plastic Surgery
252d
Cleared
Sep 16, 2022
ECHELON ENDOPATH Staple Line Reinforcement
General & Plastic Surgery
130d
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