Medical Device Manufacturer · US , North Haven , CT

Covidien

130 submissions · 126 cleared · Since 2008
130
Total
126
Cleared
0
Denied

Covidien — FDA 510(k) Submissions

Covidien has submitted 130 FDA 510(k) premarket notifications since 2008, of which 126 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Staple, Implantable, Electrosurgical, Cutting & Coagulation & Accessories, Laparoscope, General & Plastic Surgery, Sleeve, Limb, Compressible, Tube Tracheostomy And Tube Cuff . Use the specialty filter in the sidebar to narrow results.

130 devices
1–25 of 130
Sofsilk? Coated Braided Silk Suture
K241486 · GAP Suture, Nonabsorbable, Silk · General & Plastic Surgery
Dec 2024 193d
Mon-a-Therm? General Purpose Temperature Probe 400TM (90050, 90044)
K240077 · FLL Continuous Measurement... · General Hospital
Aug 2024 223d
GIA? Stapler with Tri-Staple? Technology
K231934 · GAG Stapler, Surgical · General & Plastic Surgery
Oct 2023 119d
MaxTack? Motorized Fixation Device
K231240 · OCW Endoscopic Tissue... · General & Plastic Surgery
Sep 2023 133d
Shiley? Pediatric Oral/Nasal Endotracheal Tube with TaperGuard? Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
K223130 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Aug 2023 331d
TA? Stapler and Loading Unit with DST Series? Technology
K231491 · GAG Stapler, Surgical · General & Plastic Surgery
Aug 2023 85d
EEA?Circular Stapler with Tri-Staple? Technology and OrVil? Transoral Circular Stapler Anvil
K232126 · GAG Stapler, Surgical · General & Plastic Surgery
Aug 2023 30d
Tri-Staple? 2.0 Black Circular Reloads (for use with Signia? Circular Adapters)
K221629 · GAG Stapler, Surgical · General & Plastic Surgery
Feb 2023 261d
EEA Circular Stapler with Tri-Staple Technology
K221771 · GDW Staple, Implantable · General & Plastic Surgery
Nov 2022 162d
Signia? Small Diameter Reloads Including Regular (Round) Tip Version
K222641 · GDW Staple, Implantable · General & Plastic Surgery
Nov 2022 89d
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
K221003 · GDW Staple, Implantable · General & Plastic Surgery
Sep 2022 178d
ProGrip Self-Gripping Polypropylene Mesh
K220540 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Sep 2022 209d
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
K213818 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jun 2022 202d
GIA Auto Suture Stapler with DST Series Technology
K221013 · GDW Staple, Implantable · General & Plastic Surgery
May 2022 30d
EEA Circular Stapler with Tri-Staple Technology
K221005 · GDW Staple, Implantable · General & Plastic Surgery
Apr 2022 24d
GIA Stapler with Tri-Staple Technology
K221006 · GDW Staple, Implantable · General & Plastic Surgery
Apr 2022 24d
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
K203762 · CCK Analyzer, Gas,... · Anesthesiology
Sep 2021 268d
EEA Circular Stapler with Tri-Staple Technology
K202507 · GDW Staple, Implantable · General & Plastic Surgery
Jan 2021 143d
GIA Stapler with Tri-Staple Technology
K202701 · GDW Staple, Implantable · General & Plastic Surgery
Dec 2020 82d
Tri-Staple 2.0 Reloads
K202864 · GDW Staple, Implantable · General & Plastic Surgery
Oct 2020 30d
VersaOne Reusable Positioning Trocar System
K201805 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 2020 56d
Signia Stapler (with new software)
K201672 · GDW Staple, Implantable · General & Plastic Surgery
Jul 2020 28d
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
K193077 · JOH Tube Tracheostomy And... · Anesthesiology
Jun 2020 209d
GIA Stapler with Tri-Staple Technology
K192720 · GDW Staple, Implantable · General & Plastic Surgery
Mar 2020 168d
EEA Circular Stapler with Tri-Staple Technology
K192330 · GDW Staple, Implantable · General & Plastic Surgery
Jan 2020 149d

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