BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KARL STORZ SE & CO KG

    Reg #: 3014342096 · FEI: 3014342096 · Expires 2026
    View on FDA
    Products
    149
    Proprietary Names
    397
    Establishment Types
    1
    Classifications
    149

    Registration Details

    Registration Name
    KARL STORZ SE & CO KG
    Registration Number
    3014342096
    FEI Number
    3014342096
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dr.-Karl-Storz-Str. 34
    City
    TUTTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K001630
    PMA Number
    H040005

    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
    Correspondent
    Leigh Spotten

    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
    Endoscope, Neurological GWG
    Tray, Surgical, Instrument FSM
    Electrode, Electrosurgical JOS
    Laparoscope, Gynecologic (And Accessories) HET
    Laparoscope, General & Plastic Surgery GCJ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Endoscopic Irrigation/Suction System OCX
    Bronchoscope (Flexible Or Rigid) EOQ
    Hysteroscope (And Accessories) HIH
    Confocal Optical Imaging OWN
    Kit, Nephroscope FGA
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Cystourethroscope FBO
    Arthroscope HRX
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use PYO
    Camera, Television, Endoscopic, Without Audio FWF
    Insufflator, Laparoscopic HIF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Headlamp, Operating, Battery-Operated HPP
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Resectoscope, Working Element FDC
    Laryngoscope, Nasopharyngoscope EQN
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Powered Laser Surgical Instrument GEX
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Pump, Air, Non-Manual, For Endoscope FEQ
    Led Light Source NTN
    Forceps, Biopsy, Electric KGE
    Dissector, Surgical, General & Plastic Surgery GDI
    Snare, Flexible FDI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Lithotriptor, Electro-Hydraulic FFK
    Urethrotome EZO
    Insufflator, Hysteroscopic HIG
    Endoscopic Central Control Unit ODA
    Replacement, Ossicular Prosthesis, Total ETA
    Prosthesis, Partial Ossicular Replacement ETB
    Chair And Table, Medical KMN
    Mediastinoscope, Surgical EWY
    Instrument, Ent Manual Surgical LRC
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Otoscope ERA
    Telescope, Laryngeal-Bronchial ENZ
    Bur, Ear, Nose And Throat EQJ
    Light Source, Endoscope, Xenon Arc GCT
    Gastroscope And Accessories, Flexible/Rigid FDS
    Hysteroscope Accessories NWW
    Forceps, Biopsy, Non-Electric FCL
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Angioscope LYK
    Accessories, Cleaning Brushes, For Endoscope MNL
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Camera, Ophthalmic, Ac-Powered HKI
    Light Source, Fiberoptic, Routine FCW
    Esophagoscope (Flexible Or Rigid) EOX
    Bur, Surgical, General & Plastic Surgery GFF
    Accessories, Arthroscopic NBH
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Lithotriptor, Ultrasonic FEO
    Urethroscope FGC
    System, Irrigation, Urological LJH
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Drape, Microscope, Ophthalmic HMW
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Endoscope, Rigid GCM
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    System, Image Processing, Radiological LLZ
    Light, Headband, Surgical FSR
    Light Source, Photographic, Fiberoptic FCR
    Image, Illumination, Fiberoptic, For Endoscope FFS
    Instrument, Surgical, Non-Powered HAO
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Speculum, Ent EPY
    Attachment, Eyepiece, For Insertion Of Prescription Lens FDZ
    Basin For Endoscope Reprocessing PHT
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Laryngoscope, Non-Rigid CAL
    Evacuator, Gastro-Urology KQT
    Obturator, For Endoscope FEC
    Trocar, Gastro-Urology FBQ
    Endoscopic Contamination Prevention Sheath ODB
    Container, Liquid Medication, Graduated KYW
    Camera, Cine, Endoscopic, With Audio FTS
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Amnioscope, Transabdominal (Fetoscope) (And Accessories) HFA
    Holder, Ear Speculum JYK
    Retractor, Ent KAL
    Insufflator, Endoscopic Vessel Harvesting OSV
    Drape, Surgical, Exempt PUI
    Tubing, Pressure And Accessories BYX
    Tubing, Noninvasive GAZ
    Endoscope Holder OCV
    Screw, Fixation, Bone HWC
    Bulb, Inflation, For Endoscope FCY
    Vaginoscope And Accessories MOK
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Transilluminator, Fiber Optic MQW
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Dislodger, Stone, Biliary LQR
    Holder, Needle, Gastroenterologic FHQ
    Catheter And Tip, Suction JOL
    Laryngoscope, Rigid CCW
    Gag, Mouth KBN
    Tube, Smoke Removal, Endoscopic FCZ
    Bougie, Urological FAX
    Dilator, Urethral, Mechanical FAH
    Dilator, Urethral KOE
    Dilator, Catheter, Ureteral EZN
    Orthopedic Manual Surgical Instrument LXH
    Colonoscope And Accessories, Flexible/Rigid FDF
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Knife, Ent KTG
    Syringe, Irrigating (Non Dental) KYZ
    Fork, Tuning GWX
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Tubing And Tubing/Filter Fits NVT
    Blower, Powder, Ent KCL
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Light, Surgical, Accessories FTA
    Catheter, Balloon Type GBA
    Endoscope, Fetal Blood Sampling (And Accessories) HGK
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Speculum, Illuminated FXF
    Source, Carrier, Fiberoptic Light EQH
    Hook, Microsurgical Ear JYL
    Light Source System, Diagnostic Endoscopic OAY
    Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC
    Cannula, Surgical, General & Plastic Surgery GEA
    Laryngostroboscope EQL
    Neurological Stereotaxic Instrument HAW
    Instruments, Dental Hand DZN
    Clamp, Vascular DXC
    Evacuator, Bladder, Manually Operated FFD
    Unit, Operative Dental EIA
    System, Digital Image Communications, Radiological LMD
    Proctoscope GCF
    Instrument, Microsurgical GZX
    Microscope, Surgical EPT
    Table, Operating-Room, Electrical GDC
    Instrument, Manual, Surgical, General Use MDM
    Accessories, Catheter, G-U KNY
    Mirror, Ent KAI
    Motor, Surgical Instrument, Ac-Powered GEY

    Proprietary Names

    Bipolar Coagulation Electrodes Instrument Tray Take-Apart Bipolar Forceps Telescopes Holders HYDROMAT, Model 263110 20 UNIMAT Plus ENDOMAT LC PUMP Video Flexible ENT Endoscope System MTP Extraction Bags Trocars, Cannulae and Sheaths Flexible Hysteroscope, 10.5 Fr KARL STORZ ICG Imaging System Nephroscope, Adult & Pediatric GI CCU KARL STORZ Cysto-Urethro-Fiberscope Take-Apart Forceps Laryngoscope Accessories Tape and bandage, adhesive, adjustable closing mechanism, OTC use Adaptors for Documentation KARL STORZ ENDOVISION HYSTEROCAM KARL STORZ ENDOVISION UROCAM KARL STORZ HYSTEROCAM Electronic LAPAROFLATOR Bipolar Coagulating Forceps Mono High Freq Cords LED Headlight KS70 KARL STORZ Bipolar Resectoscopes with HF Cable STEINER Electromechanic Morcellator Cutting Loop Elctrodes Modification MULTIDRIVE II Mini Shaver CLEARVISION Lens Irrigation System KSEA CLEARVISION LE H1 Camera Head Spinoscope Device Imaging Storage KARL STORZ Laryngoscopes and Accessories Bridges, Adaptors MTP CLEARVISION Disp Tubing Set Laser Accessories CO2mbi LED SCB Insulated Biopsy Forceps, Grasping KARL STORZ Image1 S Camera Control Unit Model 27080 LITHOTRIPTOR System Knives, Curettes Hysteromat II SCB/Covidien Force Triad Interface Module FISCH Titanium Mid Ear Prostheses FISCH TITANIUM MID Chair and Table, Medical KARL STORZ Mediastinoscopes and Instruments ENT Forceps, Scissors, and Punches CHARDONNES Morcellation Knife KARL STORZ Cholangiography Set ENT Rigid Telescopes DCI Endoscope Micro-Instrum. for Cochlear Implant Flexible HD Cysto-Urethroscope System KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ VIDEO GASTROSCOPES Video Gastroscopes Hysteroscope and accessories CCL Vaginal Extractor and Acc's Insulated Biopsy Forceps KARL STORZ FORCEPS EPIDUROSCOPE URETERO-RENOSCOPES/URETEROSCOPE Laproscopy Continuous Flow RESECTOSCOPES Vascular Fiberscopes Cleaning Brushes and kits Calculase II Powered Laser Surgical Instrument Vein Discission Grasping, Biopsy, and Spoon Forceps Camera, ophthalmic, ac-powered Power LED 175 Sialoendoscopes and Accessories Needles Drill Laproscope Arthroforce SilCut Shoulder Pro SilGrasp Xenon 100 UNIDRIVE II/II Plus & ENT Accessori Vaporization Electrodes Uterine Manipulator Take Apart Suture Forceps Series 11274 Flex. URETEROSCOPE CALCUSON CMOS Video Rhino Laryngoscope SCB/VALLEY LAB Force FX Interface Medi Pack Suction/Drainage Tubes, Cannulae HOPKINS I/II Autoclavable Telescope Endomat Select (Model Number: UP210) Semi-Rigid Microendoscope & Acc. 12G-SDI CABLE, ARTHROPUMP Plus LED light source Model 27224P Continuous Flow Pump Flexible Video Cysto-Urethroscope CO2 ARTHROFLATOR HEMPFLING Dilation Set Rotocut G1 Morcellator, Electromech Drape MTP Disposable Trocar Valves Arthroscopic Telescopes Flexible Video-urethro-cystoscope KARL STORZ FLEXIBLE VIDEO- Stone Basket Light Cable Insulated ELECTROSUGRICAL Instrum. SCB/CONMED ESU INTERFACE MODULE Optical Mediastinoscope 11274AC Flex. CHOLEDOCHOSCOPE Plastic Surgery Accessories KOH Needle Holders, Suturing Forcep Electronic LAPAROFLATOR (10 LPM) Trans-Nasal Esophagoscopes KARL STORZ Endoscopic Accessories for Urology KARL STORZ Ped. Cysto-Urethro-Fiberscope AIDA Compact II System ADVANCED IMAGE AND DATA Snares KARL STORZ Fiber Telescopes for Urology Headband Headlight KARL STORZ suction and irrigation system HD Mediastinoscope Distending DIVERTICULOSCOPE Xenon Light Source/Flash CMOS Endoscopes SSU Instr Set Percut Discect/Nucleotomy Nonpowered neurosurgical instrument REMORGIDA Forceps S-Pilot Speculum, ENT Take-Apart Scissors TIPCAM 1S 3D System EQUIMAT Model 203020 20 KSEA CLEARVISION II, MODEL 40334120 Semi-Rigid Micro-Endoscpes & Acc. EYEPIECE ATTACHMENT FOR INS Basin for endoscope reprocessing NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) 26025UC HAMOU Elctrnc HYSTEROFLATOR MVM 3.3 MM MICROENDOSCOPE DCI VIDEO LARYNGOSCOPE Tubing with Connector Neuro-Fiberscope Telescpes, Rigid/Mgnifying/KS VARIA Forceps, ENDO/LAP Electronic LAPAROFLATOR (20 LPM) Mono Ball/Needle/Loop Electrodes Xenon Nova Light Source HAMOU ENDOMAT Disposable Tubing Set UNIDRIVE S III ENT KOH Needle Holders, Suture Forceps Endoscopy Instrument CO2 HYDROMAT Pump for Irrigation Medicine Cups Unidrive Shaver ARTHROSCOPY Blades Rigid Telescopes Miniature Telescope for Urology AIDA w/ DICOM and HL7 Interface Rhino-Laryngo-Bronco Fiberscope Continuous Flow Cystoscope Contact Microlaryngoscope Ureteroscope and accessories, flexible/rigid Telescope Bridges & Adaptors Cold Knife Model 27086C Ultrasonic LITHOTRITE Obturators, Cannula Sheaths Camera Monopolr Cord, Endoscpc Hi-Frequncy Neuro FIBERSCOPE TUBING SET FOR LAPAROSCOPIC INSUFFL TUBING Catheters Fetoscopy Set HARTMANN Ear Speculum Xenon Light Source (175W) 201320-20 HOPKINS Telescopes XENON NOPPVA RETRACTOR Autocon II 400 Electrosurgical Gen Slim Nasopharyngolaryngoscope ENDOFLATOR 40&50 AUTOCON II 200 Electrosurg Generat Insulated Dissecting Cannulae Bipolar Electrotome KARL STORZ OTOSCOPE OTOSCOPE Ped VANCAILLIE Take Apart Bip Instr Cover KARL STORZ Urological Laser Accessories ENDOSPINE Oper Tube & Telesc Bridge KARL STORZ PRESSURE T VACUSAFE TUBING SETS Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing SPIES 3D System KS Lock MegaFix Perforated Bioabsorbable MTP ARTHROUMP TUBING SET CALCUSPLIT Insufflation Bulb Suction Catheters KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) 300W Light Source, Non-flash ENDOTIP System Infant Balloon VAGINOSCOPES N20 ENDOFLATOR Semi-rigid Hysteroscope Power LED 175 Light Fountain Light Fountain 50 Watts 7.5 Fr. Flexible CHOLEDOSCHOSCOPE HD-View Knives,Curettes,Hooks,Needles Mono Coag Needle Electrode Fluid Light Cables Twin Transilluminator Fiber Optic Light Cables RHINO-PHARYNGO-LARYNGO FIBERSCOPE Adult/Pede VISCOUS Fluid Inject.Set Take Apart Rotating Grasping Forcep Obstetrical and Gynecological Surgical Devices KARL STORZ NEEDLE HOLDERS ARTHROPUMP DISP, Tubing Set KARL STORZ Endoscopic ICG Imaging System GELET Uretero-Renoscope Sunction Tube KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S MAHNES Take-Apart Bipol Coag Forcep KARL STORZ LARYNGOSCOPE ENT Surgical Instrument MOUTH GAG MVM 7.5 French Flex. HYSTEROSCOPE Cholangiography Set KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE GAAB Rigid NEUROENDOSCOPES Image Processing System Smoke Removal Tube KARL STORZ ICG System Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories UROPUMP Disposable Tubing Set Wound Closure Instruments C-Cam BOUGIES and Dilators Ortho Manual Surgical Instruments Flexible HD Video Rhino-Laryngoscope System KARL STORZ VIDEO LOWER Video Lower G.I. Endoscope System Flexible CMOS Video-Cysto Urethroscope Esophagoscope and Accessories 495N Series Fibr Optic Light Cables MVM 3.3 MM Micro-Endoscope KNIFE, ENT SYRINGE, IRRIGATING (NON DENTAL) Tuning Fork Bipolar Electrodes Nasopharyngoscope Endoscope Accessory EQUIMAT, Model 203020 20 Instruments, Bipolar Coagulation KARL STORZ Pediatric Cysto-Urethro-Fiberscope HYSTEROSCOPIC INSU Powder Blower and Accessories UNIMAT 45 KARL STORZ MODEL 28200C SAWAHLE Electromech. Morcellator Resectoscopes Ureter Resectoscope SCB/STERIS OR-Light Interface Box ENDOSCOPE ACCESSORIES Intra-Handpieces & Accessories Elec Endoflator, Model 264305 20 VISCOUS Fluid Injection Set Thoracic Surgery Instruments UNIMAT 12 ARTHRO PUMP Suction/Irrigation Tubes Insulated Cannulae & Suction Tubes ENDOFLATOR + CMOS Video-Rhino-Laryngoscope System Bronchoscope Large Joint Arthroscopy Set Intubation Fiberscope UNIDRIVE SIII System IMAGE1 SCB Media Control Miniature Endoscope Karl Storz MegaFix-C Composite Image 1 SPIES Flexible CHOLEDOCHOSCOPE HAMOU ENDOMAT KARL STORZ ICG Imaging System with RUBINA Lens System TAMBERGER-SACHASE INTRANASAL DRILL Telepack + KSEA Monopolar Resectoscopes Scalp Blood Collection Set Flexible Intubation Video Endoscope – Sterile (FIVE-S) Sterilization Trays KARL STORZ NAV1 Electromagnetic Navigation System Powershaver System S2 AUTOCON III 400 Percutaneous Nephroscope System Insulated Scissors & Rectal Snares Flex. HYSTEROSCOPE LAPAROCAM Monopolar Coagulating Electrodes Speculum Endoscope Cold Knife Blades Puncture, Injction, ENDOSCPIC VERES MegaFix-T Titanium Screw Zero Wire Operating LARYNGOSCOPES & Accs HD View KARL STORZ FIBEROPTIC Mono Vaporization Electrodes Microsurgical Ear UROMAT Light source system, diagnostic endoscopic Mono Coag Ball Electrodes SCB-RUI (Realistic User Interface) SINGLE-USE TISSUE TRAP FILTER W/ADAPTER CLICKLINE Scissors Inserts for single use 11274AB Flex Pediatric BRONCHOSCOPE KARL STORZ SURGICAL CANNULA Fiberscope KARL STORZ PULSAR II Retractors,Probes,Dissectors,Hooks Image1 S CCU, Image1 S 4U camera head KARL STORZ Shuntscope CO2 Endoflator Bronchoscopes ENT Stent Applicator Forceps Endoscope Accessories Flexible Video-Uretero-Renoscope Flex-XC Navigation Panel Unit Carcinoma Gauges Dental Hand Instruments Neuroscope and Accessories Instr, TX of Carpal Tunnel Syndrome Deployable Cardiovascular Clamp Dilators, Reducers, Sleeves KARL STORZ BLADDER EVACUATOR Saphenous Vein Harvesting Set Dental Endoscopes Flexible Choledochoscope Mono Coag Needle, Loop Electrodes NEO NEO IP OR1 SCB CONTROL KARL STORZ HOPKINS Telescopes MVM 7.5 French Flex. URETEROSCOPE FLEX-X2 Percutaneous Foraminoscopy Set Nasopharyngo/Broncho/Tracheoscopes CALCULASE HOLMIUM LASE CALCULASE Holmium Laser & Acc. CALCULASE HOLMIUM LASER Protoscopes, Sigmoidoscopes, Acc. THERMOFLATOR, Model 26 4320 20 Cystoscope 78FAJ, Fiberoptic 78GDB Endomat Select Endoflator LC ENT/NEURO/OMF System and Accessory AUTOCON II 400 Electrosurgical Gen. Unidrive SIII ENT Modification to ENDOTIP System New Generation Trocars Micro Surgical Instruments Flexible Trocar Sleeves TIPCAM1 Rubina Video Endoscope System CALCUTRIPT Elctrohydraulc LITHR SYS Laparoscope SSU Flexible Video-Uretero-Renoscope SCB Interface Control #20090120 Microcast HD Pro Microcast 4K Pro VITOM Flexible Video-Uretero-Choledochoscope-System VOICE1 SCB R-UI Speech Control App General/Plastic Surgery Instruments manual surgical instrument ENT Catheters, MANDRIN, Plugs, Connect Semi-Rigid Micro-Endoscpes & Acces. Endoscope Holder Scissors, ENDO/LAP MIrror SACHSE DRILL Series 11274 Flexible Fiberscope Laproscopy Insstruments

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility