Data / Medical devices / United States / Covidien
Covidien: FDA-registered device maker in Boulder, CO, United States, 88 510(k) clearances
Covidien is registered with the FDA (registration 1717344) in Boulder, CO, United States. It lists 11 device types. The FDA files 88 510(k) clearances under its listings, the newest dated September 15, 2026. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1717344
- Address
- 6044 Longbow Court, Boulder, CO, United States, 80301
- Owner or operator
- Covidien llc (1282497)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- June 29, 1992
- Registered through
- 2026
- Brand names listed
- 01-00XX Series, Drape, ATLAS, Adapters, Argon 3" Flexible Electrode, E3530-3, Argon 6" Flexible Electrode, E3530-6, BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider, BZ4212A, Bipolar Footswitch, Bipolar Forceps and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2026 | K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 12, 2024 | K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 23, 2023 | K223158 | LigaSure XP Maryland Jaw Sealer/Divider | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 25, 2022 | K203150 | Cool-tip RF Ablation System E Series | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 15, 2021 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 23, 2021 | K202917 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 10, 2020 | K200427 | Sonicision Cordless Ultrasonic Dissector | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 31, 2020 | K200455 | Trigger Switch and Cord | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| March 2, 2020 | K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 19, 2019 | K193004 | Monopolar Cord | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| July 12, 2019 | K191601 | Valleylab FT10 Electrosurgical Platform | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 12, 2019 | K191064 | Argon Handset | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| May 8, 2019 | K183126 | Electrosurgical accessory | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| February 19, 2019 | K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| December 19, 2018 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| July 17, 2018 | K180915 | Sonicision Reusable Sterilization Tray | KCT | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 21, 2018 | K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 19, 2018 | K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 26, 2018 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 21, 2018 | K180192 | Emprint Ablation Visualization Application | LLZ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 2, 2018 | K173281 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 16, 2017 | K170170 | Valleylab FT10 Electrosurgical Platform | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 16, 2016 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 19, 2016 | K160290 | Valleylab REM Polyhesive Infant Patient Return Electrode | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 5, 2016 | K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 17, 2015 | K152031 | New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter. | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 10, 2015 | K151649 | Valleylab FT10 Electrosurgical Platform | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 4, 2015 | K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 27, 2015 | K142929 | Ligasure Blunt Tip Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 14, 2015 | K142335 | RapidVac Smoke Evacuator System | FYD | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 14, 2014 | K141153 | LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 7, 2014 | K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | LFL | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| April 28, 2014 | K133821 | EMPRINT ABLATION SYSTEM | NEY | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 28, 2013 | K131170 | SONICISION STERILIZATION TRAY | KCT | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| September 5, 2012 | K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | GEI | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| May 6, 2011 | K102913 | FORCETRIAD | GEI | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | accessdata.fda.gov |
| March 16, 2011 | K103375 | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Medtek Devices, Inc. | accessdata.fda.gov |
| February 24, 2011 | K101797 | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T | LFL | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco | accessdata.fda.gov |
| October 16, 2009 | K092879 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| May 2, 2007 | K070446 | COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL | GEI | Substantially Equivalent | Valleylab,A Division of Tyco Healthcare Group LP | accessdata.fda.gov |
| March 6, 2007 | K070162 | FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS | GEI | Substantially Equivalent | Valleylab,A Division of Tyco Healthcare Group LP | accessdata.fda.gov |
| November 29, 2006 | K063195 | LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| October 24, 2006 | K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| March 15, 2006 | K053290 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| August 11, 2005 | K051644 | VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| July 22, 2005 | K051627 | VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| January 5, 2005 | K043273 | LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS | GEI | Substantially Equivalent | Valleylab | accessdata.fda.gov |
| November 30, 2004 | K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | MMP | Substantially Equivalent | Guangzhou Fortunique , Ltd. | accessdata.fda.gov |
| October 3, 2003 | K032702 | VIVATIP MICROWAVE ABLATION PROBE | GEI | Substantially Equivalent | Vivant Medical, Inc. | accessdata.fda.gov |
| May 29, 2003 | K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| April 4, 2003 | K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | GEI | Substantially Equivalent | Radionics, Inc. | accessdata.fda.gov |
| June 18, 2002 | K011676 | VIVAWAVE MICROWAVE SYSTEM | NEY | Substantially Equivalent | Vivant Medical, Inc. | accessdata.fda.gov |
| February 25, 2002 | K014201 | AARON REUSABLE ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| March 26, 2001 | K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| March 7, 2000 | K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| March 5, 1999 | K984552 | COOL-TIP RF SYSTEM | GEI | Substantially Equivalent | Radionics, Inc. | accessdata.fda.gov |
| September 14, 1998 | K982749 | MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 14, 1998 | K982743 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| June 29, 1998 | K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | FYD | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| October 29, 1997 | K973297 | COSMAN COAGULATOR (CC-1) SYSTEM | GEI | Substantially Equivalent | Radionics, Inc. | accessdata.fda.gov |
| March 28, 1997 | K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| March 11, 1997 | K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 5, 1996 | K964175 | VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| August 30, 1996 | K962044 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| February 1, 1996 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| August 21, 1995 | K953195 | VALLEYLAB FORCE 300 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| June 5, 1995 | K944602 | VALLEYLAB FORCE FX | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| February 10, 1995 | K950188 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 30, 1994 | K944244 | MODEL E278OR-ASP SERIES RETRACTABLE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 9, 1994 | K945260 | E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| May 17, 1994 | K942183 | E2550 REUSABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| February 12, 1994 | K926481 | VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| September 13, 1993 | K924732 | PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| July 27, 1993 | K931028 | VALLEYLAB RETRACTABLE ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| April 23, 1993 | K926415 | VALLEYLAB CURRENT MONITOR, E3350 & E3351 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| September 18, 1991 | K912614 | ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | Andrew Surgical | accessdata.fda.gov |
| December 31, 1990 | K904560 | VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 28, 1990 | K904545 | FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| May 6, 1986 | K861036 | E7509 POLYHESIVE II PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| September 21, 1982 | K822572 | POLYHESIVE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 10, 1981 | K813071 | E2508 DISPOSABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| July 28, 1981 | K811820 | BIPOLAR COAGULATING FORCEPS | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| May 20, 1980 | K801153 | VALLEYLAB RETURN ELECTRODE MONITOR | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| September 12, 1979 | K791639 | MODEL E2515 ELECTROSURGICAL ACCESSORY | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| October 24, 1978 | K781511 | LECTROSWITCH MODEL E2502B | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 15, 2019 | 82244 | Class II | Terminated | Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, t | Potential for the sterile packaging to be compromised | accessdata.fda.gov |
| November 4, 2011 | 60462 | Not yet classified | Terminated | LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Man | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. | accessdata.fda.gov |
| December 8, 2010 | 57498 | Not yet classified | Terminated | Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 m | During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue. | accessdata.fda.gov |
| February 6, 2009 | 59754 | Not yet classified | Terminated | Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures. | Generator may deliver full power when a lower power is selected. | accessdata.fda.gov |
| April 21, 2006 | 35283 | Not yet classified | Terminated | Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue. | Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode. | accessdata.fda.gov |
| January 27, 2006 | 34573 | Not yet classified | Terminated | LigaSure Atlas Laparoscopic Vessel Sealer/Divider | Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal. | accessdata.fda.gov |
| July 16, 2003 | 26842 | Not yet classified | Terminated | Radionics Disposable Grounding Plate | Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn. | accessdata.fda.gov |
Compare with other makers
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- All makers of System, Ablation, Microwave And Accessories
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- All makers of Instrument, Ultrasonic Surgical
Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.