BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KARL STORZ SE & CO. KG

    Reg #: 3006546082 · FEI: 3006546082 · Expires 2026
    View on FDA
    Products
    62
    Proprietary Names
    116
    Establishment Types
    2
    Classifications
    62

    Registration Details

    Registration Name
    KARL STORZ SE & CO. KG
    Registration Number
    3006546082
    FEI Number
    3006546082
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Elsa-Brandstrom-Weg 11-21
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K243653

    Owner / Operator

    Firm Name
    KARL STORZ SE & CO KG
    Operator Number
    8010119
    Address
    Dr.-Karl-Storz-Strasse 34,
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE

    US Agent

    Business Name
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Contact Name
    Anja Fair
    Address
    2151 E Grand Ave
    City
    El Segundo
    State
    CA
    ZIP
    90245
    Country
    US
    Email
    [email protected]
    Phone
    346 8168200

    Products

    Device Name Product Code
    Arthroscope HRX
    Orthopedic Manual Surgical Instrument LXH
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Laparoscope, General & Plastic Surgery GCJ
    Hysteroscope (And Accessories) HIH
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Bronchoscope (Flexible Or Rigid) EOQ
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Forceps, Biopsy, Electric KGE
    Dissector, Surgical, General & Plastic Surgery GDI
    Snare, Flexible FDI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Laparoscope, Gynecologic (And Accessories) HET
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Endoscope, Neurological GWG
    Led Light Source NTN
    Lithotriptor, Ultrasonic FEO
    Electrode, Electrosurgical JOS
    Bougie, Urological FAX
    Dilator, Urethral, Mechanical FAH
    Dilator, Urethral KOE
    Dilator, Catheter, Ureteral EZN
    Powered Laser Surgical Instrument GEX
    Accessories, Cleaning Brushes, For Endoscope MNL
    Mediastinoscope, Surgical EWY
    Esophagoscope (Flexible Or Rigid) EOX
    Cystourethroscope FBO
    Resectoscope, Working Element FDC
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Kit, Nephroscope FGA
    Otoscope ERA
    Light Source, Endoscope, Xenon Arc GCT
    Lithotriptor, Electro-Hydraulic FFK
    Instrument, Surgical, Non-Powered HAO
    Light Source System, Diagnostic Endoscopic OAY
    Speculum, Illuminated FXF
    Laryngoscope, Rigid CCW
    Forceps, Biopsy, Non-Electric FCL
    Urethroscope FGC
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Accessories, Arthroscopic NBH
    Instrument, Ent Manual Surgical LRC
    Laryngoscope, Nasopharyngoscope EQN
    Hysteroscope Accessories NWW
    Endoscope Holder OCV
    Obturator, For Endoscope FEC
    Trocar, Gastro-Urology FBQ
    Endoscopic Contamination Prevention Sheath ODB
    Light Source, Fiberoptic, Routine FCW
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Proctoscope GCF
    Light, Headband, Surgical FSR
    Colonoscope And Accessories, Flexible/Rigid FDF
    Urethrotome EZO
    Headlamp, Operating, Battery-Operated HPP
    Microscope, Surgical EPT
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Blower, Powder, Ent KCL
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    Large Joint Arthroscopy Set Ortho Manual Surgical Instruments Mono Coag Ball Electrodes Insulated Dissecting Cannulae Wound Closure Instruments Sialoendoscopes and Accessories Take-Apart Scissors Uterine Manipulator ARTHROPUMP DISP, Tubing Set Distending DIVERTICULOSCOPE Bipolar Coagulating Forceps REMORGIDA Forceps KARL STORZ HOPKINS Telescopes for Urology Percutaneous Foraminoscopy Set DCI Endoscope Insulated Biopsy Forceps, Grasping GAAB Rigid NEUROENDOSCOPES Retractors,Probes,Dissectors,Hooks Insulated Scissors & Rectal Snares LED light source Model 27086C Ultrasonic LITHOTRITE Take-Apart Bipolar Forceps BOUGIES and Dilators Take-Apart Forceps Laser Accessories Cleaning Brushes and kits Suction/Irrigation Tubes KARL STORZ Mediastinoscopes and Instruments KOH Needle Holders, Suture Forceps Esophagoscope and Accessories KSEA Monopolar Resectoscopes New Generation Trocars CLEARVISION Lens Irrigation System KSEA CLEARVISION LE Nephroscope, Adult & Pediatric Insulated Cannulae & Suction Tubes KARL STORZ OTOSCOPE OTOSCOPE Instruments, Bipolar Coagulation Xenon 100 CALCUSPLIT MAHNES Take-Apart Bipol Coag Forcep Nonpowered neurosurgical instrument Trocars, Cannulae and Sheaths Mono Coag Needle Electrode Modification to ENDOTIP System KARL STORZ Endoscopic Accessories for Urology Light source system, diagnostic endoscopic Insulated ELECTROSUGRICAL Instrum. Suction/Drainage Tubes, Cannulae Operating LARYNGOSCOPES & Accs Speculum KARL STORZ LARYNGOSCOPE Rigid Telescopes Endoscope Bronchoscopes Grasping, Biopsy, and Spoon Forceps Dilators, Reducers, Sleeves Mono Coag Needle, Loop Electrodes Semi-Rigid Microendoscope & Acc. Fluid Light Cables HOPKINS I/II Autoclavable Telescope Forceps, ENDO/LAP Rotocut G1 Morcellator, Electromech Ped VANCAILLIE Take Apart Bip Instr KARL STORZ suction and irrigation system Bipolar Coagulation Electrodes KARL STORZ Bipolar Resectoscopes with HF Cable Arthroforce SilCut Shoulder Pro SilGrasp ENT Surgical Instrument KARL STORZ Laryngoscopes and Accessories Adaptors for Documentation Mono Ball/Needle/Loop Electrodes Monopolar Coagulating Electrodes Hysteroscope and accessories Obturators, Cannula Sheaths Optical Mediastinoscope Xenon Nova Light Source Endoscope Holder Cholangiography Set KS Lock Neuroscope and Accessories Resectoscopes Thoracic Surgery Instruments Endoscopy Instrument Power LED 175 Light Fountain Light Fountain 50 Watts Laryngoscope Accessories Semi-Rigid Micro-Endoscpes & Acc. Flexible Trocar Sleeves KARL STORZ Urological Laser Accessories Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories Protoscopes, Sigmoidoscopes, Acc. Headband Headlight KARL STORZ VIDEO LOWER Video Lower G.I. Endoscope System Cold Knife CALCUSON LED Headlight KS70 KARL STORZ FORCEPS Microcast HD Pro Microcast 4K Pro VITOM Continuous Flow RESECTOSCOPES Obstetrical and Gynecological Surgical Devices Percutaneous Nephroscope System Scissors, ENDO/LAP Continuous Flow Cystoscope Powder Blower and Accessories Cold Knife Blades General/Plastic Surgery Instruments manual surgical instrument ENT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device