Medical Device Manufacturer · US , Blue Ash , OH

Ethicon Endo-Surgery, LLC

69 submissions · 69 cleared · Since 2006
69
Total
69
Cleared
0
Denied

Ethicon Endo-Surgery, LLC — FDA 510(k) Submissions

Ethicon Endo-Surgery, LLC has submitted 69 FDA 510(k) premarket notifications since 2006, of which 69 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Staple, Implantable, Instrument, Ultrasonic Surgical, Electrosurgical, Cutting & Coagulation & Accessories, Clip, Implantable, Mesh, Surgical, Absorbable, Staple Line Reinforcement . Use the specialty filter in the sidebar to narrow results.

69 devices
1–25 of 69
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
K252906 · OXC Mesh, Surgical,... · General & Plastic Surgery
Jan 2026 119d
ETHICON? 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)
K252739 · GDW Staple, Implantable · General & Plastic Surgery
Dec 2025 111d
ETHICON 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)
K250835 · GDW Staple, Implantable · General & Plastic Surgery
May 2025 55d
ECHELON 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)
K243276 · GDW Staple, Implantable · General & Plastic Surgery
Feb 2025 132d
ECHELON 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)
K241630 · GDW Staple, Implantable · General & Plastic Surgery
Oct 2024 144d
ECHELON 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)
K241629 · GAG Stapler, Surgical · General & Plastic Surgery
Jul 2024 27d
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
K232313 · FZP Clip, Implantable · General & Plastic Surgery
Aug 2023 27d
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)
K230387 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2023 58d
HARMONIC 700 Shears
K221790 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Feb 2023 252d
ECHELON ENDOPATH Staple Line Reinforcement
K221343 · OXC Mesh, Surgical,... · General & Plastic Surgery
Sep 2022 130d
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 · GAG Stapler, Surgical · General & Plastic Surgery
Apr 2022 142d
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
May 2021 24d
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
K201066 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2021 275d
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length
K201696 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2021 214d
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
K202665 · GDW Staple, Implantable · General & Plastic Surgery
Oct 2020 31d
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K201280 · GDW Staple, Implantable · General & Plastic Surgery
Jul 2020 75d
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
K200420 · GDW Staple, Implantable · General & Plastic Surgery
Jun 2020 130d
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
K200841 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2020 41d
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
K191555 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Feb 2020 261d
Echelon Endopath Staple Line Reinforcement
K190937 · OXC Mesh, Surgical,... · General & Plastic Surgery
Oct 2019 187d
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
K183435 · GDW Staple, Implantable · General & Plastic Surgery
Feb 2019 57d
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
K181488 · FZP Clip, Implantable · General & Plastic Surgery
Oct 2018 146d
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K181653 · GDW Staple, Implantable · General & Plastic Surgery
Sep 2018 88d
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length
K180403 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2018 98d
Endopath Electrosurgery Probe Plus II
K180031 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2018 123d
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