Covidien

FDA Device Registration & Listing · Lafayette, CO, US · Registration 3026612481

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026612481
FEI Number
3026612481
Entity Name
Covidien
City/State/Country
Lafayette, CO, US
Establishment Address
200 Medtronic Drive, Lafayette, CO 80026, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Covidien llc (Owner Number: 1282497)
Owner / Operator Contact Address
15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OptiMumm Smoke Prefilter Reducer Adapter, E3665 RapidVac Wand, Laser Resistant, SEA3725 OptiMumm ULPA Filter, E3625 OptiMumm Smoke Sponge Guard Tubing, E3635 RapidVac Tubing, SEA3705 OptiMumm Smoke Reducer Fitting, E3655 OptiMumm Smoke Tubing, E3645 RapidVac Tubing, SEA3710 OptiMumm Smoke Prefilter Reducer Adapter, E3660 RapidVac Laparoscopic Tubing, SEA3720 OptiMumm Smoke Prefilter, E3630 RapidVac Tubing with Sponge Guard, SEA3715 Reusable Handswitching Pencil Valleylab™ Rocker Switch Pencil ERBE, Reuseable, E2100E Valleylab™ Rocker Switch Pencil Reusable, E2100 Lectroswitch Model E2502B Valleylab Hex-locking Blade Electrode, Reusable, 2.75" (7 cm), E1020 LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644 LigaSure™ Tissue Fusion Footswitch, Purple, LS0300 Valleylab™ FX8 FX Series Energy Platform TissueFect Tissue Sensing Technology, VLFX8GEN Emprint Ablation System with Thermosphere Technology Valleylab™ Solid Laparoscopic Electrode, Wire L-Hook Solid, 45 cm, E2773-45 Valleylab™ Laparoscopic Cylindrical Electrode, Hollow, 28 cm, E2786-28 Valleylab ™ Laparoscopic Handset, Four-Function, E2750 and E2750NSB Valleylab™ Solid Laparoscopic Electrode, Flat L-Hook Solid, 36 cm, E2774-36 Valleylab™ Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2782R-28ASP Valleylab™ Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Holes, 28 cm, E2781R-28ASP Valleylab™ Laparoscopic Flat L-Hook Electrode, Hollow, 28 cm, E2784-28 Valleylab™ Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 36 cm, E2783R-36ASP Valleylab™ Laparoscopic Wire L-hook Electrode, Hollow, 28 cm, E2783-28 Valleylab™ Solid Laparoscopic Curved Spatula Electrode, Solid, 36 cm, E2771-36 Valleylab™ Laparoscopic Wire J-hook Electrode, 28 cm, E2782-28 Valleylab™ Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 28 cm, E2783R-28ASP Valleylab™ Laparoscopic Curved Spatula Electrode, Hollow, 28 cm, E2781-28 Valleylab™ Laparoscopic Straight Spatula Electrode, Hollow, 28 cm, E2780-28 Valleylab™ Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2784R-28ASP Valleylab™ Solid Laparoscopic Electrode, Wire J-Hook Solid, 36 cm, E2772-36 Valleylab™ Solid Laparoscopic Electrode, Wire L-Hook Solid, 36 cm, E2773-36 Valleylab™ Solid Laparoscopic Curved Spatula Electrode, Solid, 45 cm, E2771-45 Valleylab™ Solid Laparoscopic Straight Spatula Electrode, Solid, 36 cm, E2770-36 Laparascopic Electrodes w/Retractab Valleylab™ Argon Handset, E2520H Valleylab™ Flexible Argon Electrode Coagulation Only, E2530-3 Valleylab™ Flexible Argon Electrode Coagulation Only, E2530-6 Valleylab™ Argon Tungsten Sharp Needle Electrode, E2532 Valleylab™ Flexible Laparoscopic Argon Electrode Coagulation Only, E2530-28 Emprint" Reinforced Long Percutaneous Antenna with Thermosphere" Technology, CA30L2 Emprint" Reinforced Short Percutaneous Antenna with Thermosphere" Technology, CA15L2 Emprint" Reinforced Standard Percutaneous Antenna with Thermosphere" Technology, CA20L2 Cool-tip Valleylab FT10 Electrosurgical Platform, VLFT10GEN Emprint Procedure Planning Application CAMPA Emprint Procedure Planning Application CAMPV Emprint Procedure Planning Application CAMPP Valleylab Suction Coagulator Valleylab™ Suction Coagulator, E3305 Valleylab™ Suction Coagulator, E3310 and E3310NSB LigaSure Curved, Small Jaw, Open Sealer/Divider LigaSure Advance Valleylab Return Electrode Monitor Valleylab™ Multiple Return/S Cord Adapter, E0507-B Sonicision Reusable Sterilization Tray, SCSTA LigaSure™ Dolphin Tip Laparoscopic Sealer/Divider, LS1500 LigaSure™ Tissue Fusion Electrode Straight Jaw, LS2071 Ligasure™ Tissue Fusion Electrode Curved Jaw, LS3112 LigaSure Atlas™ Tissue Fusion Laparoscopic Instrument, LS1037 LigaSure™ Tissue Fusion Electrode Angled Jaw, LS2111 LigaSure™ Vessel Sealing System, LigaSure 8 LigaSure Atlas™ Tissue Fusion Open Instrument, LS1020 LigaSure™ Dolphin Tip Laparoscopic Sealer/Divider LigaSure™ Dolphin Tip Open Sealer/Divider, LS1520 Ligasure™ Tissue Fusion Electrode Curved Jaw, LS3092 ForceTriad™ Remote Control Activation Kit, FTRCKIT Sonicision™ 7 Reusable Generator, SCG7AB Sonicision™ Reusable Battery Pack Sonicision™ 7 Reusable Generator, SCG7AA Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 39 cm, SCD7A39 Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 26 cm, SCD7A26 Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 48 cm, SCD7A48 Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 13 cm, SCD7A13 Emprint™ Ablation Visualization Application, CAVA Valleylab¿ Trigger switch and cord Valleylab™ Trigger Switch and Cord 10' (3 m), E0520 Emprint SX Table Top Field Generator Cart (CAFGCART1) Emprint SX Laparoscopic Ultrasound Tracking Sensor (CABK8666L) Emprint SX Ablation Platform (CASYS100) Emprint SX Laparoscopic Ultrasound Tracking Sensor (CAAL9150L) Emprint SX Open Ultrasound Tracking Sensor (CAAL9132) Emprint SX Field Generator Spacers (Bed Pads) (CAFGSP1) Emprint Standard Navigation Antenna with Thermosphere Technology (CA20L2N) Emprint SX Table Top Field Generator (CAFG1) Emprint SX Ultrasound Surgical Navigation (software) Application (CAUS1SN) Emprint SX Long Navigation Antenna with Thermosphere Technology (CA30L3N) Emprint SX Short Navigation Antenna with Thermosphere Technology (CA15L2N) Emprint SX Open Ultrasound Tracking Sensor (CABK8816) Polyhesive Patient Return Electrode Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507 Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7508 Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507DB Valleylab™ Non-REM Polyhesive™ Patient Return Electrode, E7506 Valleylab™ SM Smoke Management Extended Nozzle Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode Cool-tip RF Ablation System E Series Force TriVerse™ Electrosurgical Device Holster 10' (3 m), FT3000 Force TriVerse™ Electrosurgical Device Holster 15' (4.6 m), FT300DB Electrodes Valleylab™ Button Switch Pencil Needle Electrode, Holster, E2516HDA Valleylab™ Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB Valleylab™ Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB Valleylab™ Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB Valleylab™ Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB Valleylab™ Button Switch Pencil, E2516, E2516GNSB, and E2516NSB LigaSure™ Blunt Tip Open Sealer/Divider, LF1623 LigaSure™ Blunt Tip Laparoscopic Sealer/Divider, LF1644 Valleylab REM patient return electrode cord Polyhesive II Patient Return Electr REM patient return electrode cord Valleylab™ REM™ Patient Return Electrode Cord, Reusable, 15' (4.6 m), E0560 Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7509B Valleylab™ Cord Clamp ERBE™, Reusable 15/ (4.6 m), E0560E Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7509 Force GSU TM System Force GSU TM Handset Valleylab™ Argon Gas Tank, GT100 Coated Electrodes LigaSure™ Exact Dissector, Nano-coated, LF2019 Pencils LigaSure¿ Single pedal footswitch ForceTriad¿ Electrosurgical Generator ForceTriad¿ Three pedal footswitch Bipolar Footswitch LigaSure™ Tissue Fusion Footswitch, Orange, LF0500 Valleylab™ Bipolar Standard Footswitch, E6009 Monopolar Cords ForceTriad Bipolar Resection Activation Kit ForceTriad™ Bipolar Resection Activation Kit, FTBRKIT Bipolar Forceps Cord ForceTriad™ Bipolar Resection Cord Stroz™, Reusable, 15' (4.6m), FT0021S ForceTriad™ Monopolar Cord 15' (4.6 m), FT0510 ForceTriad™ Bipolar Resection Cord Wolf, Reusable, 15' (4.6m), FT0022W Valleylab™ Bipolar Forceps Cord, 12' (3.6 m), E0512 ForceTriad Electrosurgical Generato Laparoscopic Cord Valleylab™ Monopolar Laparoscopic Cord Reusable 10' (3 m), E2999 Vivatip Microwave Ablation Probe Model E2515 Electrosurgical Accesso LigaSure Maryland Jaw Thoracic Sealer Divider One-step Sealing, Nano-coated (LF1930T) BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider, BZ4212A Valleylab Blade Electrode Valleylab¿ Ball Electrode Valleylab¿ Straight Extension Valleylab Needle Electrode Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm, E1005 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB Valleylab Ball Electrode, Reusable, 5.6 mm, E1002 Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm), E1551XNSB Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB Valleylab Straight Extension, 34.3 cm, E1504 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552 Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm), E1003 Valleylab Ball Electrode, Reusable, 3.2 mm, E1000 Valleylab Straight Extension, 13 cm, E1502 Valleylab Ball Electrode, 5 mm, E1550 LigaSure™ Exact Dissector Nano-coated, LF2019 RapidVac ULPA Filter RapidVac Smoke Evacuator 220V, SE3695 RapidVac Smoke Evacuator Filter, SEA3700 RapidVac Smoke Evacuator 110V, SE3690 Force TriVerse Sonicision Sterilization Tray Valleylab monopolar cord Valleylab™ Monopolar Cord 10' (3 m), E0503 LXMJ44S - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, One-Step Sealing, Nano-Coated, 5 mm - 44 cm LXMJ23L - LigaSure™ XP Maryland Jaw Sealer/Divider, Open, Latching Handle, Nano-Coated, 5 mm - 23 cm LXMJ37L - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, Latching Handle, Nano-Coated, 5 mm - 37 cm LXMJ23S - LigaSure™ XP Maryland Jaw Sealer/Divider, Open, One-Step Sealing, Nano-Coated, 5 mm - 23 cm LXMJ37S - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, One-Step Sealing, Nano-Coated, 5 mm - 37 cm LXMJ44L - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, Latching Handle, Nano-Coated, 5 mm - 44 cm Valleylab™ FT10 Electrosurgical Generator Valleylab™ FT10 Energy Platform Software Version 5 Valleylab™ FT10 Energy Platform Valleylab™ FT10 Vessel Sealing Generator Laparoscopic Handswitch/Electrodes Suction Coagulators Valleylab™ REM Polyhesive™ Adult Patient Return Electrode for Symplicity™ Generator Valleylab SM Smoke Management Pencil Adapter Reusable Footswitching Bipolar Cord Valleylab™ Bipolar Forceps Cord, Reusable, 15' (4.6 m), E0020V Valleylab™ Bipolar Forceps Cord, Storz™, Reusable, 15' (4.6 m), E0022W Valleylab™ Bipolar Forceps Cord, Storz™, Reusable, 15' (4.6 m), E0021S Cool-Tip RF System Force EZ Valleylab Smoke Evacuation Rocker Switch Pencil, Edge Blade Electrode, 10 foot, SEP5000 Valleylab Smoke Evacuation Extension Tube, 4 inches, SEA50595 Valleylab Smoke Evacuation Rocker Switch Pencil, Edge Blade Electrode, 15 foot, SEP5015 Valleylab Smoke Evacuation Extension Tube, Edge Blade Electrode, 4 inches, SEA54506 Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil, Edge Blade Electrode, 15 foot, SEP6015 Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil, Edge Blade Electrode, 10 foot, SEP6000 Valleylab™ FT10 FT Series Energy Platform, VLFT10GEN Valleylab™ FT10 Bipolar Adapter, VLFT10ADP1 LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, LF1737 LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, LF4318 LigaSure™ Maryland Jaw Open Sealer/Divider One-step Sealing, LF1723 LigaSure™ Blunt Tip Laparoscopic Sealer/Divider, LF1637 LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, LF1744 Lectrobrasive(R) E2401 LigaSure Curved, Small jaw Open Sealer/Divider, LF1212A Lectrovac, Valleylab Models Valleylab™ Suction Coagulator, E2608-6 Sonicision 26cm dissector (SCD26) Sonicision 28 cm dissector (SCD48) Valleylab™ REM Polyhesive™ Neonatal Patient Return Electrode, E7512 Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator, VLLS10GEN Footswitches Adapters Valleylab™ REM™ Patient Return Electrode Adapter, E0600 Valleylab™ Monopolar Adapter , E0502-1 Valleylab™ Universal Monopolar Adapter, E0017 Valleylab™ Active Adapter, E0005-3C

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 1999-07-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-03-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-07
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2020-09-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2017-01-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2019-09-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-09-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-08-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-02-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-01-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-07-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-06-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-01-11
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-03-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2017-12-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-07-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-02-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-06-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-06-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-09-24
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2007-12-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-06
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2020-07-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-02-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-02-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-07-18
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2024-07-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-01-29
QGI Air-Handling Apparatus Accessory General, Plastic Surgery Class 1 878.5080 2025-06-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-12-18
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2021-04-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-03-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-12-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2016-12-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-05-08
BWA Unit, Electrosurgical And Coagulation, With Accessories General, Plastic Surgery Class 2 878.4400 2009-06-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Covidien llc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8020889 Mallinckrodt Medical ATHLONE Westmeath, IE
3006451981 Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai, CN
8044004 ORIDION MEDICAL 1987 LTD. JERUSALEM, IL
1282497 Covidien LLC MANSFIELD, MA, US
9681384 Covidien Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19
K142547 Covidien Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm 2014-12-09
K130320 Covidien BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW 2014-02-04
K241486 Covidien Sofsilk™ Coated Braided Silk Suture 2024-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0210-2022 Covidien Llc 2
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026612481. Last updated year: 2026. Please use registration number 3026612481 when referencing this establishment in official correspondence.
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