Data / Medical devices / United States / Covidien
Covidien: FDA-registered device maker in Lafayette, CO, United States, 91 510(k) clearances
Covidien is registered with the FDA (registration 3026612481) in Lafayette, CO, United States. It lists 11 device types. The FDA files 91 510(k) clearances under its listings, the newest dated September 15, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3026612481
- Address
- 200 Medtronic Drive, Lafayette, CO, United States, 80026
- Owner or operator
- Covidien llc (1282497)
- Roles
- Specification developer
- First device listed
- June 29, 1992
- Registered through
- 2026
- Brand names listed
- ATLAS, Adapters, BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider, BZ4212A, Bipolar Footswitch, Bipolar Forceps Cord, Blade Electrodes, Coated Electrodes, Cool-Tip Generator 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 |
| July 1, 2024 | K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6) | 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 |
| April 15, 2021 | K210338 | Edge Insulated Blade Electrode | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 23, 2021 | K202917 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 26, 2020 | K200796 | Emprint Ablation System with Thermosphere Technology | NEY | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 10, 2020 | K200427 | Sonicision Cordless Ultrasonic Dissector | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 2, 2020 | K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 12, 2019 | K191601 | Valleylab FT10 Electrosurgical Platform | GEI | Substantially Equivalent | Covidien | 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 |
| November 19, 2018 | K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil | GEI | Substantially Equivalent | Covidien | 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 |
| September 1, 2017 | K171358 | Emprint SX Ablation Platform and Accessories | NEY | Substantially Equivalent | Coviden, LLC | 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 |
| December 6, 2016 | K163105 | Emprint Ablation System | NEY | 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 |
| September 10, 2015 | K151649 | Valleylab FT10 Electrosurgical Platform | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 8, 2015 | K152286 | LigaSure Curved, Small Jaw, Open Sealer/Divider | 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 |
| April 3, 2015 | K143654 | Valleylab LS10 Generator | GEI | Substantially Equivalent | Covidien, LLC | 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 |
| September 17, 2014 | K142048 | EMPRINT PROCEDURE PLANNING APPLICATION | LLZ | Substantially Equivalent | Covidien, LLC | 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 31, 2011 | K110268 | FORCETRIAD ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Covidien Lp, Formerly Know AS Valleylab, A Divison | accessdata.fda.gov |
| May 6, 2011 | K102913 | FORCETRIAD | GEI | Substantially Equivalent | Covidien, Formerly Valleylab, A Division of Tyco H | 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 |
| September 11, 2009 | K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | GEI | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| March 17, 2008 | K073450 | SUTTER ELECTROSURGICAL CABLES | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | 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 |
| 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 |
| 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 |
| March 26, 2001 | K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 22, 2000 | K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | GEI | Substantially Equivalent | Aaron Medical Industries | 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 |
| August 28, 1998 | K981916 | LIGASURE VESSEL SEALING SYSTEM | GEI | Substantially Equivalent | Valleylab, Inc. | 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 6, 1995 | K946177 | VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM | 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 |
| 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 |
| July 18, 1988 | K882646 | LECTROBRASIVE(R) E2401 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 14, 1987 | K874794 | E600B FOOTSWITCH | BWA | 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 |
| May 20, 1980 | K801153 | VALLEYLAB RETURN ELECTRODE MONITOR | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| October 4, 1979 | K791752 | LECTROVAC, VALLEYLAB MODELS | 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 21, 2024 | 94127 | Class II | Ongoing | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLE | accessdata.fda.gov |
| November 16, 2023 | 93561 | Class II | Ongoing | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD | Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Unit, Electrosurgical And Coagulation, With Accessories
- All makers of System, Ablation, Microwave And Accessories
- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- All makers of Instrument, Ultrasonic Surgical
- All makers of Apparatus, Exhaust, 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.