ClearanceBrief
Company · DE

Karl Storz SE & CO. KG

FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.

34510(k) clearances (17 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FGBUreteroscope And Accessories, Flexible/Rigid4
OWNConfocal Optical Imaging4
GCJLaparoscope, General & Plastic Surgery3
HIGInsufflator, Hysteroscopic3
EOBNasopharyngoscope (Flexible Or Rigid)2
FBOCystourethroscope2
HIFInsufflator, Laparoscopic2
HIHHysteroscope (And Accessories)2
EOQBronchoscope (Flexible Or Rigid)1
EOXEsophagoscope (Flexible Or Rigid)1
EWYMediastinoscope, Surgical1
FAJCystoscope And Accessories, Flexible/Rigid1
FGAKit, Nephroscope1
FJLResectoscope1
GEXPowered Laser Surgical Instrument1
GWGEndoscope, Neurological1
HRXArthroscope1
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)1
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered1
ODAEndoscopic Central Control Unit1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 14, 2026K260581KARL STORZ Flexible Video Neuro-Endoscope
Karl Storz SE & CO. KG, DE
GWG
Sep 25, 2026K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205
Karl Storz SE & CO. KG, DE
HIH
Sep 24, 2026K254303KARL STORZ SUPRALOOP
Karl Storz SE & CO. KG
KNF
Sep 18, 2026K261102UNIDRIVE Select System
Karl Storz SE & CO. KG, DE
HIH
Sep 15, 2026K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45°
Karl Storz SE & CO. KG, DE
EOB
Sep 1, 2026K260884UNIDRIVE Select System
Karl Storz SE & CO. KG, DE
GCJ
Aug 26, 2026K254103HOPKINS Telescopes for Arthroscopy
Karl Storz SE & CO. KG, DE
HRX
Aug 19, 2026K260209ENDOFLATOR+; Smart Smoke Evacuation
Karl Storz SE & CO. KG, DE
HIF
Jul 16, 2026K261706Endomat Select (UP220)
KARL STORZ SE & CO. KG, DE
HIG
Jun 3, 2026K252800KARL STORZ Endoscopic Accessories for Urology
Karl Storz SE & CO. KG, DE
OCZ
May 11, 2026K254228KARL STORZ Trocars with Valve Seals
Karl Storz SE & CO. KG
GCJ
Mar 2, 2026K260003KARL STORZ Mediastinoscopes and Instruments
Karl Storz SE & CO. KG, DE
EWY
Feb 26, 2026K254242KARL STORZ ICG Imaging System with RUBINA® Lens
Karl Storz SE & CO. KG, DE
OWN
Feb 12, 2026K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)
Karl Storz SE & CO. KG, DE
OWN
Dec 5, 2025K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
Karl Storz SE & CO. KG, DE
EOQ
Nov 22, 2025K250927KARL STORZ Cholangiography Set
Karl Storz SE & CO. KG, DE
GCJ
Nov 18, 2025K253411Miniature Telescope for Urology (27033AA)
Karl Storz SE & CO. KG, DE
FGB
Sep 22, 2025K250388ENDOFLATOR +
Karl Storz SE & CO. KG, DE
HIF
Aug 13, 2025K243653KARL STORZ HOPKINS Telescopes for Urology
Karl Storz SE & CO. KG, DE
FAJ
Jun 6, 2025K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Karl Storz SE & CO. KG, DE
FGB
May 2, 2025K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Karl Storz SE & CO. KG, DE
FBO
Nov 27, 2024K243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Karl Storz SE & CO. KG, DE
FBO
Aug 1, 2024K241945KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
Karl Storz SE & CO. KG, DE
FGB
Jul 25, 2024K233372KARL STORZ Fiber Telescopes for Urology
Karl Storz SE & CO. KG, DE
FGB
May 7, 2024K232486KARL STORZ Monopolar Resectoscopes with HF Cable
Karl Storz SE & CO. KG, DE
FJL
May 1, 2024K232370Percutaneous Nephroscope System
Karl Storz SE & CO. KG, DE
FGA
Nov 21, 2023K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
Karl Storz SE & CO. KG, DE
OWN
Nov 6, 2023K232857KARL STORZ ICG Imaging System
Karl Storz SE & CO. KG, DE
OWN
Oct 3, 2023K232406KARL STORZ OR1™ SCB CONTROL (WU300)
Karl Storz SE & CO. KG, DE
ODA
Sep 8, 2023K230535KARL STORZ Urological Laser Accessories
Karl Storz SE & CO. KG, DE
GEX
Jul 22, 2020K201355Endomat Select, IBS Shaver Software, License
Karl Storz SE & CO. KG, DE
HIG
Jan 27, 2020K192090CMOS Video Rhino-Laryngoscope SSU
Karl Storz SE & CO. KG, DE
EOB
Jan 24, 2020K192523CMOS Video Esophagoscope SSU
Karl Storz SE & CO. KG, DE
EOX
Oct 31, 2018K180735Endomat Select
Karl Storz SE & CO. KG, DE
HIG

Latest recalls

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