Covidien, LLC - FDA 510(k) Cleared Devices
Recent clearances: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT), Instrument Exit Point on Touch Surgery™ Aide, Capnostream™35 Portable Respiratory Monitor (PM35MN)
90
Total
87
Cleared
1
Denied
FDA 510(k) Regulatory Record - Covidien, LLC General & Plastic Surgery ✕
44 devices
Cleared
Jul 01, 2026
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)
General & Plastic Surgery
230d
Cleared
Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
General & Plastic Surgery
174d
Cleared
CT
Dec 03, 2025
Hugo™ RAS System
General & Plastic Surgery
268d
Cleared
Jul 12, 2024
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN...
General & Plastic Surgery
84d
Cleared
Jul 01, 2024
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m)...
General & Plastic Surgery
123d
Cleared
Jan 23, 2023
LigaSure™ XP Maryland Jaw Sealer/Divider
General & Plastic Surgery
108d
Cleared
Feb 25, 2022
Cool-tip RF Ablation System E Series
General & Plastic Surgery
491d
Cleared
Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
General & Plastic Surgery
115d
Cleared
Apr 15, 2021
Edge Insulated Blade Electrode
General & Plastic Surgery
69d
Cleared
Mar 23, 2021
LigaSure Exact Dissector, Nano-coated
General & Plastic Surgery
175d
Cleared
Dec 17, 2020
Emprint SX Ablation Platform with Thermosphere Technology
General & Plastic Surgery
38d
Cleared
Aug 26, 2020
Emprint Ablation System with Thermosphere Technology
General & Plastic Surgery
153d
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