FDA Registration Active 🇩🇪 Germany

KARL STORZ SE & CO. KG

Reg #: 3010707607 · FEI: 3010707607 · Expires 2026
Products
123
Proprietary Names
276
Establishment Types
3
Classifications
123

Registration Details

Registration Name
KARL STORZ SE & CO. KG
Registration Number
3010707607
FEI Number
3010707607
Status
Active
Expiry Year
2026
Initial Importer
No
Address
TAKE-OFF GEWERBEPARK 83
City
NEUHAUSEN OBECK 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
Phone
346 8168200

Products

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

Proprietary Names

Trans-Nasal Esophagoscopes Micro Surgical Instruments SACHSE DRILL Instrument Tray Nasopharyngoscope Mono High Freq Cords Endomat Select (Model Number: UP210) Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing Cleaning Brushes and kits GAAB Rigid NEUROENDOSCOPES REMORGIDA Forceps ENT Stent Applicator Forceps HD-View VACUSAFE TUBING SETS DCI Endoscope Flexible Hysteroscope, 10.5 Fr THERMOFLATOR, Model 26 4320 20 KARL STORZ FIBEROPTIC Flexible CMOS Video-Cysto Urethroscope FISCH Titanium Mid Ear Prostheses FISCH TITANIUM MID Vaporization Electrodes Chair and Table, Medical Insulated Dissecting Cannulae Neuroscope and Accessories CALCUSPLIT KARL STORZ Bipolar Resectoscopes with HF Cable AUTOCON II 400 Electrosurgical Gen. Spinoscope Insulated Biopsy Forceps Flexible Trocar Sleeves Sialoendoscopes and Accessories Model 27080 LITHOTRIPTOR System HAMOU ENDOMAT Disposable Tubing Set Grasping, Biopsy, and Spoon Forceps General/Plastic Surgery Instruments manual surgical instrument ENT Semi-Rigid Microendoscope & Acc. New Generation Trocars Flexible Choledochoscope Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories Continuous Flow Cystoscope KARL STORZ OTOSCOPE OTOSCOPE Tuning Fork Uterine Manipulator Video Flexible ENT Endoscope System HYDROMAT, Model 263110 20 Trocars, Cannulae and Sheaths Suction/Irrigation Tubes Arthroforce SilCut Shoulder Pro SilGrasp KARL STORZ BLADDER EVACUATOR Retractors,Probes,Dissectors,Hooks KARL STORZ Mediastinoscopes and Instruments KARL STORZ NAV1 Electromagnetic Navigation System KARL STORZ NEEDLE HOLDERS Nonpowered neurosurgical instrument KARL STORZ SURGICAL CANNULA AIDA Compact II System ADVANCED IMAGE AND DATA Monopolar Coagulating Electrodes Bipolar Electrodes Arthroscopic Telescopes Scissors, ENDO/LAP Headband Headlight Telescpes, Rigid/Mgnifying/KS VARIA Navigation Panel Unit Protoscopes, Sigmoidoscopes, Acc. MTP Disposable Trocar Valves Laryngoscope Accessories CLICKLINE Scissors Inserts for single use Series 11274 Flex. URETEROSCOPE SCB/STERIS OR-Light Interface Box Insufflation Bulb ENT Rigid Telescopes Micro-Instrum. for Cochlear Implant Smoke Removal Tube S-Pilot Infant Balloon VAGINOSCOPES ARTHRO PUMP Basin for endoscope reprocessing Light source system, diagnostic endoscopic Cold Knife Blades Plastic Surgery Accessories Autocon II 400 Electrosurgical Gen Endoscope Speculum, ENT Take-Apart Scissors Dental Hand Instruments Esophagoscope and Accessories Semi-Rigid Micro-Endoscpes & Acc. AIDA w/ DICOM and HL7 Interface Snares CALCUSON DCI VIDEO LARYNGOSCOPE MIrror KARL STORZ PULSAR II Modification to ENDOTIP System Catheters, MANDRIN, Plugs, Connect Take Apart Rotating Grasping Forcep KARL STORZ ENDOVISION HYSTEROCAM KARL STORZ ENDOVISION UROCAM KARL STORZ HYSTEROCAM Powershaver System S2 KARL STORZ Shuntscope Bronchoscopes Insulated ELECTROSUGRICAL Instrum. EQUIMAT, Model 203020 20 TIPCAM 1S 3D System GELET Uretero-Renoscope Intra-Handpieces & Accessories Sterilization Trays Mono Coag Needle, Loop Electrodes Mono Coag Needle Electrode Flexible Video-Uretero-Renoscope Flex-XC Ureter Resectoscope Suction Catheters HYSTEROSCOPIC INSU LED light source Endoscopy Instrument Saphenous Vein Harvesting Set Powder Blower and Accessories Dental Endoscopes Large Joint Arthroscopy Set Wound Closure Instruments Sunction Tube Light Cable Dilators, Reducers, Sleeves KARL STORZ Endoscopic ICG Imaging System UNIMAT Plus Operating LARYNGOSCOPES & Accs TUBING SET FOR LAPAROSCOPIC INSUFFL TUBING ENDOFLATOR + Cover Laproscope Rotocut G1 Morcellator, Electromech Rigid Telescopes Monopolr Cord, Endoscpc Hi-Frequncy Catheters Hysteroscope and accessories KSEA Monopolar Resectoscopes Obturators, Cannula Sheaths KARL STORZ LARYNGOSCOPE Semi-rigid Hysteroscope Telescope Bridges & Adaptors CO2 HYDROMAT Pump for Irrigation KARL STORZ HOPKINS Telescopes for Urology Image 1 SPIES UROMAT Deployable Cardiovascular Clamp Neuro FIBERSCOPE Forceps, ENDO/LAP Power LED 175 Light Fountain Light Fountain 50 Watts Puncture, Injction, ENDOSCPIC VERES ENDOFLATOR 40&50 Model 27224P Continuous Flow Pump Adaptors for Documentation Endoscope Holder URETERO-RENOSCOPES/URETEROSCOPE HOPKINS I/II Autoclavable Telescope MOUTH GAG UNIMAT 12 ENDOSPINE Oper Tube & Telesc Bridge HARTMANN Ear Speculum KNIFE, ENT MAHNES Take-Apart Bipol Coag Forcep Microcast HD Pro Microcast 4K Pro VITOM Unidrive SIII ENT Xenon Nova Light Source KARL STORZ Endoscopic Accessories for Urology KARL STORZ ICG Imaging System KOH Needle Holders, Suture Forceps MTP CLEARVISION Disp Tubing Set ENT Surgical Instrument SCB/VALLEY LAB Force FX Interface Nasopharyngo/Broncho/Tracheoscopes UNIDRIVE SIII System SCB-RUI (Realistic User Interface) Mono Ball/Needle/Loop Electrodes Medicine Cups VOICE1 SCB R-UI Speech Control App ARTHROPUMP DISP, Tubing Set Contact Microlaryngoscope SPIES 3D System CLEARVISION Lens Irrigation System KSEA CLEARVISION LE 11274AB Flex Pediatric BRONCHOSCOPE Model 27086C Ultrasonic LITHOTRITE KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S MTP ARTHROUMP TUBING SET Bridges, Adaptors Rhino-Laryngo-Bronco Fiberscope SAWAHLE Electromech. Morcellator Take-Apart Bipolar Forceps RHINO-PHARYNGO-LARYNGO FIBERSCOPE Take-Apart Forceps EQUIMAT Model 203020 20 Optical Mediastinoscope Flexible CHOLEDOCHOSCOPE Semi-Rigid Micro-Endoscpes & Acces. Nephroscope, Adult & Pediatric LED Headlight KS70 Resectoscopes STEINER Electromechanic Morcellator KARL STORZ FORCEPS SYRINGE, IRRIGATING (NON DENTAL) AUTOCON III 400 MegaFix Bioabsorbable Screw UNIMAT 45 Cold Knife HAMOU ENDOMAT Suction/Drainage Tubes, Cannulae Bipolar Coagulating Forceps Thoracic Surgery Instruments SINGLE-USE TISSUE TRAP FILTER W/ADAPTER BOUGIES and Dilators Cystoscope 78FAJ, Fiberoptic 78GDB Unidrive Shaver ARTHROSCOPY Blades Instr Set Percut Discect/Nucleotomy SCB Interface Control #20090120 Mono Coag Ball Electrodes MVM 7.5 French Flex. URETEROSCOPE FLEX-X2 KOH Needle Holders, Suturing Forcep ENT/NEURO/OMF System and Accessory HEMPFLING Dilation Set Insulated Scissors & Rectal Snares Percutaneous Foraminoscopy Set Continuous Flow RESECTOSCOPES Instruments, Bipolar Coagulation 26025UC HAMOU Elctrnc HYSTEROFLATOR Ortho Manual Surgical Instruments VISCOUS Fluid Injection Set Hysteromat II MULTIDRIVE II Mini Shaver ENDOMAT LC PUMP Insulated Biopsy Forceps, Grasping Medi Pack KSEA CLEARVISION II, MODEL 40334120 Endoflator LC Fluid Light Cables Laparoscope Scalp Blood Collection Set Bipolar Coagulation Electrodes Cholangiography Set Flexible Video-urethro-cystoscope KARL STORZ FLEXIBLE VIDEO- Laser Accessories Adult/Pede VISCOUS Fluid Inject.Set Take Apart Suture Forceps TAMBERGER-SACHASE INTRANASAL DRILL KARL STORZ Flexible Video-Neuro-Endoscope System Instr, TX of Carpal Tunnel Syndrome CALCULASE HOLMIUM LASE CALCULASE Holmium Laser & Acc. CALCULASE HOLMIUM LASER Bipolar Electrotome KARL STORZ VIDEO GASTROSCOPES Video Gastroscopes Insulated Cannulae & Suction Tubes CALCUTRIPT Elctrohydraulc LITHR SYS SCB/Covidien Force Triad Interface Module Distending DIVERTICULOSCOPE UNIDRIVE II/II Plus & ENT Accessori KARL STORZ VIDEO LOWER Video Lower G.I. Endoscope System Neuro-Fiberscope

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device