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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / November 2025 / K253411

510(k) cleared

Miniature Telescope for Urology (27033AA)

Karl Storz SE & CO. KG · Nov 18, 2025 · K253411

FDA cleared the Miniature Telescope for Urology (27033AA) from Karl Storz SE & CO. KG on Nov 18, 2025 under K253411, a traditional 510(k). The device falls under product code FGB, Ureteroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 30, 2025. The decision came 49 days later, inside the 90 FDA-day goal for a 510(k).

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: 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)), K254303 (KARL STORZ SUPRALOOP), K261102 (UNIDRIVE Select System), K254299 (CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)).

Questions & Answers

What did FDA clear under K253411?

K253411 is the FDA 510(k) for Miniature Telescope for Urology (27033AA), submitted by Karl Storz SE & CO. KG. FDA's decision date was Nov 18, 2025, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Miniature Telescope for Urology (27033AA)?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K253411.

How long did the K253411 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Nov 18, 2025, 49 days later.

← All decisions in November 2025