Chrysalis Intelligence · Sponsors · Karl Storz SE & CO. KG

Karl Storz SE & CO. KG

Tuttlingen, DE · 32 510(k) clearances

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Total clearances
32
2020-01-24 → 2026-09-25
Last 12 months
16
Product codes
19
Most recent
2026-09-25
Name variants in FDA filings: Karl Storz SE & CO. KG / KARL STORZ SE & CO. KG
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OWN Confocal Optical Imaging Class II Gastroenterology, Urology 4 2026-02-26
FGB Ureteroscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 4 2025-11-18
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 3 2026-09-01
HIH Hysteroscope (And Accessories) Class II Obstetrics/Gynecology 2 2026-09-25
EOB Nasopharyngoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 2 2026-09-15
HIF Insufflator, Laparoscopic Class II Obstetrics/Gynecology 2 2026-08-19
HIG Insufflator, Hysteroscopic Class II Obstetrics/Gynecology 2 2026-07-16
FBO Cystourethroscope Class II Gastroenterology, Urology 2 2025-05-02
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Class II Obstetrics/Gynecology 1 2026-09-24
HRX Arthroscope Class II Orthopedic 1 2026-08-26
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Class II Gastroenterology, Urology 1 2026-06-03
EWY Mediastinoscope, Surgical Class II Ear, Nose, Throat 1 2026-03-02
EOQ Bronchoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 1 2025-12-05
FAJ Cystoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 1 2025-08-13
FJL Resectoscope Class II Gastroenterology, Urology 1 2024-05-07
FGA Kit, Nephroscope Class II Gastroenterology, Urology 1 2024-05-01
ODA Endoscopic Central Control Unit Class II Gastroenterology, Urology 1 2023-10-03
GEX Powered Laser Surgical Instrument Class II General, Plastic Surgery 1 2023-09-08
EOX Esophagoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 1 2020-01-24
Filings

All 510(k) clearances (32)

Date K-number Device Code Class Specialty
2026-09-25 K254252 UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) HIH Class II Obstetrics/Gynecology
2026-09-24 K254303 KARL STORZ SUPRALOOP KNF Class II Obstetrics/Gynecology
2026-09-18 K261102 UNIDRIVE Select System HIH Class II Obstetrics/Gynecology
2026-09-15 K254299 CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) EOB Class II Ear, Nose, Throat
2026-09-01 K260884 UNIDRIVE Select System GCJ Class II Gastroenterology, Urology
2026-08-26 K254103 HOPKINS Telescopes for Arthroscopy HRX Class II Orthopedic
2026-08-19 K260209 ENDOFLATOR+; Smart Smoke Evacuation HIF Class II Obstetrics/Gynecology
2026-07-16 K261706 Endomat Select (UP220) HIG Class II Obstetrics/Gynecology
2026-06-03 K252800 KARL STORZ Endoscopic Accessories for Urology OCZ Class II Gastroenterology, Urology
2026-05-11 K254228 KARL STORZ Trocars with Valve Seals GCJ Class II Gastroenterology, Urology
2026-03-02 K260003 KARL STORZ Mediastinoscopes and Instruments EWY Class II Ear, Nose, Throat
2026-02-26 K254242 KARL STORZ ICG Imaging System with RUBINA® Lens OWN Class II Gastroenterology, Urology
2026-02-12 K253972 IMAGE1 (TC400US); X-to-4U Adapter (TC040) OWN Class II Gastroenterology, Urology
2025-12-05 K251731 KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) EOQ Class II Ear, Nose, Throat
2025-11-22 K250927 KARL STORZ Cholangiography Set GCJ Class II Gastroenterology, Urology
2025-11-18 K253411 Miniature Telescope for Urology (27033AA) FGB Class II Gastroenterology, Urology
2025-09-22 K250388 ENDOFLATOR + HIF Class II Obstetrics/Gynecology
2025-08-13 K243653 KARL STORZ HOPKINS Telescopes for Urology FAJ Class II Gastroenterology, Urology
2025-06-06 K243550 KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) FGB Class II Gastroenterology, Urology
2025-05-02 K244001 KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) FBO Class II Gastroenterology, Urology
2024-11-27 K243409 KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) FBO Class II Gastroenterology, Urology
2024-08-01 K241945 KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) FGB Class II Gastroenterology, Urology
2024-07-25 K233372 KARL STORZ Fiber Telescopes for Urology FGB Class II Gastroenterology, Urology
2024-05-07 K232486 KARL STORZ Monopolar Resectoscopes with HF Cable FJL Class II Gastroenterology, Urology
2024-05-01 K232370 Percutaneous Nephroscope System FGA Class II Gastroenterology, Urology
2023-11-21 K233333 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit OWN Class II Gastroenterology, Urology
2023-11-06 K232857 KARL STORZ ICG Imaging System OWN Class II Gastroenterology, Urology
2023-10-03 K232406 KARL STORZ OR1™ SCB CONTROL (WU300) ODA Class II Gastroenterology, Urology
2023-09-08 K230535 KARL STORZ Urological Laser Accessories GEX Class II General, Plastic Surgery
2020-07-22 K201355 Endomat Select, IBS Shaver Software, License HIG Class II Obstetrics/Gynecology
2020-01-27 K192090 CMOS Video Rhino-Laryngoscope SSU EOB Class II Ear, Nose, Throat
2020-01-24 K192523 CMOS Video Esophagoscope SSU EOX Class II Ear, Nose, Throat
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence