FDA Registration Active 🇺🇸 United States

Covidien

Reg #: 1219930 · FEI: 1219930 · Expires 2026
Products
74
Proprietary Names
413
Establishment Types
5
Classifications
74

Registration Details

Registration Name
Covidien
Registration Number
1219930
FEI Number
1219930
Status
Active
Expiry Year
2026
Initial Importer
No
Address
60 Middletown Ave
City
North Haven
State
CT
ZIP
06473
Country
US

Regulatory Submissions

510(k) Number
K001895
PMA Number
P010002

Owner / Operator

Firm Name
Covidien llc
Operator Number
1282497
Address
15 HAMPSHIRE STREET, --
City
Mansfield
State
MA
Postal Code
02048
Country
US

Products

Device Name Product Code
Staple, Implantable GDW
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Electrosurgical, Cutting & Coagulation & Accessories GEI
Stapler, Surgical GAG
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile KDW
Clamp, Surgical, General & Plastic Surgery GDJ
Hysteroscope (And Accessories) HIH
Mesh, Surgical, Deployer ORQ
Laparoscope, General & Plastic Surgery GCJ
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Endoscopic Tissue Approximation Device OCW
Suture, Nonabsorbable, Silk GAP
Tube Tracheostomy And Tube Cuff JOH
Hysteroscope Accessories NWW
Staple, Fixation, Bone JDR
Drape, Surgical, Antimicrobial KKX
Screw, Fixation, Bone HWC
Clip, Implantable FZP
Apparatus, Suturing, Stomach And Intestinal FHM
Gouge, Surgical, General & Plastic Surgery GDH
Sealant, Dural NQR
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Absorbable, Natural GAL
Needle, Suturing, Disposable GAB
Motor, Surgical Instrument, Pneumatic Powered GET
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Instrument, Ultrasonic Surgical LFL
Tubes, Gastrointestinal (And Accessories) KNT
Insufflator, Hysteroscopic HIG
Instrument, Ligature Passing And Knot Tying HCF
Laryngoscope, Endoscope GCI
Agent, Absorbable Hemostatic, Non-Collagen Based LMG
Tissue Adhesive For The Topical Approximation Of Skin MPN
Powered Laser Surgical Instrument GEX
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Applier, Surgical, Clip GDO
Forceps, Obstetrical HDA
Barrier, Absorbable, Adhesion MCN
Retractor GAD
Trocar, Gastro-Urology FBQ
Surgical Instruments, G-U, Manual (And Accessories) KOA
Anti Fog Solution And Accessories, Endoscopy OCT
Accessories, Cleaning Brushes, For Endoscope MNL
Laparoscope, Gynecologic (And Accessories) HET
Probe, Uptake, Nuclear IZD
Unit, Electrosurgical And Coagulation, With Accessories BWA
Anoscope And Accessories FER
Catheter And Tip, Suction JOL
Instrument, Biopsy KNW
Kit, Surgical Instrument, Disposable KDD
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Staple, Removable (Skin) GDT
Device, Occlusion, Umbilical FOD
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Pin, Fixation, Threaded JDW
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Stents, Drains And Dilators For The Biliary Ducts FGE
Modular Electromechanical Surgical System SCV
Cystoscope And Accessories, Flexible/Rigid FAJ
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Pneumoperitoneum Needle FHO
Forceps HTD
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Drape, Surgical, Exempt PUI
Applier, Staple, Surgical, GEF
Tape, Surgical, Internal MCA
Syringe, Piston FMF
Illuminator, Fiberoptic, Surgical Field HBI
Guide, Surgical, Instrument FZX
Instrument, Clip Removal HBQ
Suture Kit OVN
Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
Catheter, Angioplasty, Peripheral, Transluminal LIT
Accessories, Cleaning, For Endoscope FEB

Proprietary Names

Auto Suture TriTis Non-Absorbable Force TriVerse Signia Circular Adapters, Tri-Staple 2 Circular Reloads AUTO SUTURE ENDO CATCH SPECIMAN BAG Purstring TRUCLEAR Operative Hysteroscope 5C- Refurbished/Service TRUCLEAR Operative Hysteroscope 5C TRUCLEAR Sheath 5C AccuMesh SPACEMAKER Purple Radial Reload Polypropylene Suture SILS Port Sofsilk SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOS Signia™ Loading Units Tri-staple 2 and Tri-staple 2.4 45mt and 60vt DG Surgilene Suture Signia Stapler Endo Lube Valleylab Suction Coagulator Valleylab™ Suction Coagulator, E3305 Valleylab™ Suction Coagulator, E3310 and E3310NSB TruClear Diagnostic Sheath Duo TruClear Operative Sheath Duo Versaport Absorbatack GIA™ Stapler with Tri-Staple™ Technology Step SD Suture Anchor DUET with Tri-Staple Endo GIA™ Reloads with Tri-Staple™ Technology Signia™ Small Diameter Reloads Tri-staple 2™ Reloads Endo GIA™ Gray Articulating Reloads SILS Articulating Hand Instruments Laproclip Surgisleeve Wound Protector IO+ Port MaxTack™ Motorized Fixation Device TriTis 12 mm Non-Absorbable Endo GIA Pancreas Indication Laparascopic Electrodes w/Retractab Premium-SurgiClip III TruClear Elite Hysteroscope Mini (includes insert) TruClear Elite Hysteroscope Plus TruClear Elite Hysteroscope Mini TruClear Elite Hysteroscope Plus (includes insert) Elite hysteroscope plus - refurbished Elite hysteroscope mini- refurbished ReliaMax ENDO STITCH Radial Expandable LigaSure™ Exact Dissector Nano-coated, LF2019 GIA PREMIUM SURGIPORT DuraSeal Spine V-Loc SurgiGut TRUCLEAR ULTRA Plus Tissue Removal Device LigaSure¿ Impact LigaSure¿ V Surgiwip ROTICULATOR ENDO DISSECT - ENDO GRASP ENDO SLIDE V-LOC NA 8 TRUCLEAR Sheath 9 TRUCLEAR Obturator TRUCLEAR Operative Hysteroscope 4 Calibration Insert Tri-StapleTM 2 Circular Reloads Visiport Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 48 cm, SCDA48 Sonicision™ Reusable Generator, SCGAA Sonicision™ Battery Charger, CBCA Sonicision™ Reusable Battery Pack, SCBA Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 39 cm, SCDA39 Sonicision™ Reusable Battery Insertion Guide, SCBIGA Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 13 cm, SCDA13 Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 26 cm, SCDA26 Surgiport Gastrisail LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944 LigaSure™ Maryland Jaw Open Sealer/Divider One-step Sealing, Nano-coated, LF1923 Hysteroscopic Outflow Tubes Set LIGATURE PASSING AND KNOT TYING ENDO CATCH CLIP IMPLANTABLE MULTAPPLIER Doubletime Trocar ENDO TA ENDO PEANUT Stratis ST Non-Absorbable Stratus Nonabsorbable ACL Fixation ENDO LUNG SILS PORT SurgiTie Micro-Needle Electrodes, E16XX Coated Electrodes Edge Needle Electrode, (6.5" (, 16.51 cm), E1452-6 Edge Insulated Blade Electrode, (4", (10.16 cm), E1455-4 and E1455-4NSB Edge Blade Electrode, (3” (, 7.62 cm), E1450G and E1450GNSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB Edge Insulated Blade Electrode, Safety Sleeve, (4" (, 10.16 cm), E1455B4 Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350H Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465NSB Edge Insulated Blade Electrode, (6.5", (16.51 cm), E1455-6 and E1455-6NSB Edge Insulated Blade Electrode, Safety Sleeve (2.75", (7 cm), E1455NSB Edge Insulated Blade Electrode, Safety Sleeve, (2.75", (7 cm), E1455BNSB Valleylab™ Insulated Micro-Needle Electrode, 9 cm, E1654B Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HGNSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB Valleylab™ Straight Micro-Needle Electrode, 2 cm, E1650 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB Edge Coated Blade Extended Electrode, ( 4" , (10.16 cm), E1450-4 Edge Blade Electrode, (4", (10.16 cm), E1450-NSB Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465 Edge™ Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350HDB Valleylab™ Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652 Edge Hex-locking Blade Electrode, (2.5” (, 6.35 cm), E1450X and E1450XNSB Edge Insulated Blade Electrode, Safety Sleeve, (2.75" (, 7 cm), E1455B Edge Insulated Needle Electrode, 6.5" (16.51 cm), E1465-6 Edge Insulated Blade Electrode, Safety Sleeve, (4", (10.16 cm), E1455B-4NSB Edge Insulated Needle Electrode, Safety Sleeve, (4", (10.16 cm), E1465B-4 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB Edge Needle Electrode, (2.8", (7.2 cm), E1452NSB Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB Edge Insulated Blade Electrode, (2.75", (7 cm), E1455 Valleylab™ Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653 Edge™ Button Switch Pencil Blade Electrode, Holster, E2450H Edge Needle Electrode, (2.8" (, 7.2 cm), E1452 Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HNSB Edge™ Pencil Blade Electrode, Holster, E2250HNSB Valleylab™ Straight Micro-Needle Electrode, 3 cm, E1651 Edge™ Pencil Blade Electrode, Holster, E2250H Edge Blade Electrode, (6.5" (, 16.51 cm), E1450-6 and E1450-6NSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS Edge Insulated Needle Electrode, Safety Sleeve, (2.8", (7.2 cm), E1465B and E1465BNSB ILAN TRUCLEAR ULTRA MINI Tissue Removal Device Veriset Topical Tissue Adhesives Endo GIA Reload SILS Stitch Endo GIA Reinforced Reload Tristaple Technology PDB VersaOne™ Bladeless and Optical 15mm Dermalon & Surgilon Minisite Blunt probe 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 Lectrovac, Valleylab Models Valleylab™ Suction Coagulator, E2608-6 iDrive Ultra GIATM Stapler with Tri-StapleTM Technology Endo Clip lll Indermil EEA Hemorrhoid stapler and Accessor AUTOSUTURE ENDOSCOPIC CLAMP Signia Small Diameter Reload Spray Shield Spray Gel SurgiPro II Versaport V2 ACUCLIP Spacekeeper LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider Nano-coated, LF4418 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 SURGIPORT SPIRAL SLEEVE General Non-Sterile Surgical Inst TRUCLEAR INCISOR" Tissue Removal Device TRUCLEAR Control Unit TRUCLEAR Tissue Removal System TRUCLEAR Operative Hysteroscope 8 TRUCLEAR Sheath 9 TRUCLEAR Obturator TRUCLEAR Footswitch TRUCLEAR Operative Hysteroscope 8- Refurbished/Service TRUCLEAR Handpiece TRUCLEAR INCISOR" Plus Tissue Removal Device Cool-Tip Generator Monosof Polysorb TRUCLEAR Calibration Insert 4 Clearify Force FX Force FX™ Electrosurgical Generator 8CS, Force FX-8CS Force FX™ Electrosurgical Generator 8CAS Autobipolar, Force FX-8CAS Force FX™ Electrosurgical Generator 8C, Force FX-8C 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 Minisite Biopsy Clearify Trocar Wipe Surgiclip" Autosonix Surgiwand II MINI STEP Miniport Navigator Copilot Reusable Handswitching Pencil Valleylab™ Rocker Switch Pencil ERBE, Reuseable, E2100E Valleylab™ Rocker Switch Pencil Reusable, E2100 Minisite Bipolar Forceps LigaSure™ Tissue Fusion Footswitch, Purple, LS0300 Premium Surgiclip Valleylab Monopolar Footswitch Valleylab™ Monopolar Footswitch, E6008B Valleylab™ Monopolar Footswitch, E6008L LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644 SILS EGIA Radial Reload ReliaCatch Bralon & Surgidac Caprosyn ENDO SHEARS 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 Versastep LigaSure Advance Tacker System STAT Tack Protack MULTAVAC Smoke Evacuation Attachment for Ele Valleylab™ Rocker Switch Pencil Holster, Smoke Attachment, E2515HS and E2515HSNSB Valleylab™ Button Switch Pencil Holster, Smoke Attachment, E2516HS 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 Versaport Bladeless VersaOne™ Bladed and Bladeless Trocars MIBB SITE MARKER SILS Procedure Kit ENDO MINI-RETRACT TriTis Absorbable SFS Stapler McKesson Skin Staplers 35 REGULAR Appose Skin Staplers Signet McKesson Skin Staplers 35 WIDE ConcordeMultifire Premium skin stapler Umbilical Tape Polysorb™ Coated Braided Absorbable Suture Premium Poly CS iDrive Ultra Sterilization Tray VERSAPORT ArthroPort VERSASEAL Ogden Anchore VersaOne™ 5mm bladed trocar EGIA AVM Model E2515 Electrosurgical Accesso LigaSure Signia™ Sterilization Tray CHEMOSITE TUNNELER ILA GIA Staplers V-Loc 90 Paramount Mini Laparoscope EGIA Ultra Black LigaSure™ Blunt Tip Open Sealer/Divider Nano-coated, LF1823 LigaSure™ Blunt Tip, Laparoscopic Sealer/Divider Nano-coated, LF1837 and LF1844 Versastep V2 Blunt Tip Trocars Hugo™ Robotically Assisted Surgery (RAS) System Dexon Endo Clip MultApplier TiCron Navigator™ GPS Extra View Sterile Balloons AS Meniscal TruClear Hysteroscope Duo Poly Surgiclip EEA OrVil Ez-Tack Biosyn Chemosite Valtrac Purse String Signia" Four-Bay Smart Charger SURGINEEDLE Thoracoport Novafil & Vascufil Gynecology Instrument Tray GYN-Pump PH304 V-Loc Reloads V-Loc 180 Lapro-Clip Tissue Approximating Forceps Sonicision 26cm dissector (SCD26) Sonicision 28 cm dissector (SCD48) SURGIWAND Stratis ST Absorbable BLUNTGRIP - SURGIGRIP Stainless Steel Sutures LigaSure Maryland Jaw Thoracic Sealer Divider One-step Sealing, Nano-coated (LF1930T) SurgiSleeve Extra Small Wound Protector iDrive Powered Stapling System VersaOne optical trocar with fixation balloon cannula VersaOne universal fixation balloon cannula Drape SigniaTM Circular Adapters Endo Clip III Gut ILA, EEA, LDS reusable staplers VersaOne™ Bladeless Trocar GastriSail™ Gastric Positioning System SurgiSleeve Wound Protector EEA'M Circular Stapler with Tri-Staple" Technology Polyester Tape V-Loc 180 4-0 Versaport RPF VersaOne™ Reusable Positioning Trocar System Extended Tip Applicator ENDO PADDLE RETRACT IRRIGATION SYSTEM VITAL VUE ILLUMINATION LigaSure¿ Atlas ATLAS Duraseal ReliaTack Valleylab™ Laparoscopic Argon Sharp Needle Electrode Retractable, E2582-28 Valleylab™ Laparoscopic Argon Blade Electrode Retractable, E2580-28 Valleylab™ Laparoscopic Argon Modified Flat L Electrode Retractable, E2581-28 Valleylab™ Laparoscopic Argon Blunt Needle Electrode Retractable, E2583-28 ENDO MINI-SHEARS Sonicision™ Torque Wrench Sonicision™ Cordless Ultrasonic Dissector (5 mm - 48 cm) Sonicision™ Cordless Ultrasonic Dissector (5 mm - 13 cm) Sonicision™ Cordless Ultrasonic Dissector Sonicision™ Reusable Generator Sonicision™ Cordless Ultrasonic Dissector (5 mm - 26 cm) Minisite Maxon Open Step Tri-Staple™ 2 Intelligent Cartridges One Step Clip Applier LigaSure™ Blunt Tip Open Sealer/Divider, LF1623 LigaSure™ Blunt Tip Laparoscopic Sealer/Divider, LF1644 EEA TAID EGIA Ultra Stapler EGIA Tristaple Reloads TriMax ROTICULATOR ENDO MINI-SHEARS AbsorbaTack Tri-Staple™ 2 Reloads ENDO GIA ROTICULATOR Staplers PDB Sterile Balloon POLY GIA EEA Stapler TRUCLEAR Operative Hysteroscope 5 TRUCLEAR Calibration Insert 2.9 TRUCLEAR Sheath 5.6 Versaport Bladeless Optical Trocar Endo Universal 65 Laproclip remover Bluntport Tan and Black Radial Reload Ogden Suture Anchor Topical Tissue Adhesive Valleylab™ REM Polyhesive™ Neonatal Patient Return Electrode, E7512 TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS SILS Port 15mm Suture Convenience Kit ENDO BAG Tri-staple 2 Reinforced Reload NanoCross Elite ANTI-FOG AbsorbaTack 30x Surgipro FRED Versaport V2 Bladeless Optical Trocar ENDO CLOSE ReliaTack Fixation Device - Deep Purchase Absorbable Tacks Endo GIA Extra Long Adapter EEA Surgical Stapler Premium Mulitfire TA

Establishment Types

Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only