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Karl Storz SE & CO. KG FDA Approvals
0 new drug approvals and 29 device clearances on file. This applicant is not matched to a listed company.
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A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| 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)510(k)Sep 25, 2026Obstetrics/Gynecology |
| KARL STORZ SUPRALOOP510(k)Sep 24, 2026Obstetrics/Gynecology |
| UNIDRIVE Select System510(k)Sep 18, 2026Obstetrics/Gynecology |
| CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)510(k)Sep 15, 2026Ear, Nose, Throat |
| UNIDRIVE Select System510(k)Sep 1, 2026Gastroenterology, Urology |
| HOPKINS Telescopes for Arthroscopy510(k)Aug 26, 2026Orthopedic |
| ENDOFLATOR+; Smart Smoke Evacuation510(k)Aug 19, 2026Obstetrics/Gynecology |
| Endomat Select (UP220)510(k)Jul 16, 2026Obstetrics/Gynecology |
| KARL STORZ Endoscopic Accessories for Urology510(k)Jun 3, 2026Gastroenterology, Urology |
| KARL STORZ Trocars with Valve Seals510(k)May 11, 2026Gastroenterology, Urology |
| KARL STORZ Mediastinoscopes and Instruments510(k)Mar 2, 2026Ear, Nose, Throat |
| KARL STORZ ICG Imaging System with RUBINA® Lens510(k)Feb 26, 2026Gastroenterology, Urology |
| IMAGE1 (TC400US); X-to-4U Adapter (TC040)510(k)Feb 12, 2026Gastroenterology, Urology |
| KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)510(k)Dec 5, 2025Ear, Nose, Throat |
| KARL STORZ Cholangiography Set510(k)Nov 22, 2025Gastroenterology, Urology |
| Miniature Telescope for Urology (27033AA)510(k)Nov 18, 2025Gastroenterology, Urology |
| ENDOFLATOR +510(k)Sep 22, 2025Obstetrics/Gynecology |
| KARL STORZ HOPKINS Telescopes for Urology510(k)Aug 13, 2025Gastroenterology, Urology |
| KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)510(k)Jun 6, 2025Gastroenterology, Urology |
| KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)510(k)May 2, 2025Gastroenterology, Urology |
| KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)510(k)Nov 27, 2024Gastroenterology, Urology |
| KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)510(k)Aug 1, 2024Gastroenterology, Urology |
| KARL STORZ Fiber Telescopes for Urology510(k)Jul 25, 2024Gastroenterology, Urology |
| KARL STORZ Monopolar Resectoscopes with HF Cable510(k)May 7, 2024Gastroenterology, Urology |
| Percutaneous Nephroscope System510(k)May 1, 2024Gastroenterology, Urology |
| KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit510(k)Nov 21, 2023Gastroenterology, Urology |
| KARL STORZ ICG Imaging System510(k)Nov 6, 2023Gastroenterology, Urology |
| KARL STORZ OR1 SCB CONTROL (WU300)510(k)Oct 3, 2023Gastroenterology, Urology |
| KARL STORZ Urological Laser Accessories510(k)Sep 8, 2023General, Plastic Surgery |