BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KARL STORZ SE & CO. KG

    Reg #: 9610617 · FEI: 3002808268 · Expires 2026
    View on FDA
    Products
    137
    Proprietary Names
    344
    Establishment Types
    4
    Classifications
    137

    Registration Details

    Registration Name
    KARL STORZ SE & CO. KG
    Registration Number
    9610617
    FEI Number
    3002808268
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dr.-Karl-Storz-Str. 11
    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
    Basin For Endoscope Reprocessing PHT
    Camera, Television, Endoscopic, Without Audio FWF
    Arthroscope HRX
    Tube, Smoke Removal, Endoscopic FCZ
    Screw, Fixation, Bone HWC
    Laparoscope, General & Plastic Surgery GCJ
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Laparoscope, Gynecologic (And Accessories) HET
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Cystourethroscope FBO
    Instrument, Ent Manual Surgical LRC
    Bronchoscope (Flexible Or Rigid) EOQ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Endoscope, Fetal Blood Sampling (And Accessories) HGK
    Esophagoscope (Flexible Or Rigid) EOX
    Laryngoscope, Rigid CCW
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Otoscope ERA
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Insufflator, Hysteroscopic HIG
    Endoscopic Irrigation/Suction System OCX
    System, Irrigation, Urological LJH
    Endoscope, Neurological GWG
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Instrument, Microsurgical GZX
    Hysteroscope Accessories NWW
    Catheter, Balloon Type GBA
    Electrode, Electrosurgical, Active, Urological FAS
    Lithotriptor, Electro-Hydraulic FFK
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Pump, Air, Non-Manual, For Endoscope FEQ
    Led Light Source NTN
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Endoscopic Central Control Unit ODA
    Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC
    Light, Surgical, Accessories FTA
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Hook, Microsurgical Ear JYL
    Mediastinoscope, Surgical EWY
    Holder, Needle, Gastroenterologic FHQ
    Endoscope, Rigid GCM
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Drape, Surgical, Exempt PUI
    Powered Laser Surgical Instrument GEX
    Resectoscope FJL
    Forceps, Biopsy, Non-Electric FCL
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Accessories, Catheter, G-U KNY
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Table, Operating-Room, Electrical GDC
    Hysteroscope (And Accessories) HIH
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Confocal Optical Imaging OWN
    Drape, Microscope, Ophthalmic HMW
    Urethrotome EZO
    Accessories, Cleaning Brushes, For Endoscope MNL
    Laryngoscope, Non-Rigid CAL
    Urethroscope FGC
    Tray, Surgical, Instrument FSM
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    System, Digital Image Communications, Radiological LMD
    Instruments, Dental Hand DZN
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Proctoscope GCF
    Angioscope LYK
    Insufflator, Laparoscopic HIF
    Neurological Stereotaxic Instrument HAW
    Light Source, Fiberoptic, Routine FCW
    Evacuator, Bladder, Manually Operated FFD
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Bougie, Urological FAX
    Dilator, Urethral, Mechanical FAH
    Dilator, Urethral KOE
    Dilator, Catheter, Ureteral EZN
    Telescope, Laryngeal-Bronchial ENZ
    Kit, Nephroscope FGA
    System, Image Processing, Radiological LLZ
    Blower, Powder, Ent KCL
    Clamp, Vascular DXC
    Bur, Ear, Nose And Throat EQJ
    Light, Headband, Surgical FSR
    Gag, Mouth KBN
    Lithotriptor, Ultrasonic FEO
    Light Source, Endoscope, Xenon Arc GCT
    Gastroscope And Accessories, Flexible/Rigid FDS
    Endoscope Holder OCV
    Chair And Table, Medical KMN
    Electrode, Electrosurgical JOS
    Bur, Surgical, General & Plastic Surgery GFF
    Tubing, Pressure And Accessories BYX
    Instrument, Manual, Surgical, General Use MDM
    Obturator, For Endoscope FEC
    Trocar, Gastro-Urology FBQ
    Endoscopic Contamination Prevention Sheath ODB
    Light Source System, Diagnostic Endoscopic OAY
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Resectoscope, Working Element FDC
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Tubing And Tubing/Filter Fits NVT
    Dislodger, Stone, Biliary LQR
    Forceps, Biopsy, Electric KGE
    Dissector, Surgical, General & Plastic Surgery GDI
    Snare, Flexible FDI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Retractor, Ent KAL
    Accessories, Arthroscopic NBH
    Evacuator, Gastro-Urology KQT
    Laryngoscope, Nasopharyngoscope EQN
    Amnioscope, Transabdominal (Fetoscope) (And Accessories) HFA
    Mirror, Ent KAI
    Unit, Operative Dental EIA
    Insufflator, Endoscopic Vessel Harvesting OSV
    Colonoscope And Accessories, Flexible/Rigid FDF
    Bulb, Inflation, For Endoscope FCY
    Syringe, Irrigating (Non Dental) KYZ
    Speculum, Ent EPY
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Fork, Tuning GWX
    Laryngostroboscope EQL
    Motor, Surgical Instrument, Ac-Powered GEY
    Microscope, Surgical EPT
    Tubing, Noninvasive GAZ
    Replacement, Ossicular Prosthesis, Total ETA
    Prosthesis, Partial Ossicular Replacement ETB
    Catheter And Tip, Suction JOL
    Cannula, Surgical, General & Plastic Surgery GEA
    Vaginoscope And Accessories MOK
    Headlamp, Operating, Battery-Operated HPP
    Orthopedic Manual Surgical Instrument LXH
    Source, Carrier, Fiberoptic Light EQH
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Instrument, Surgical, Non-Powered HAO
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device