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The Tracker / September 2026 / K261102

510(k) cleared

UNIDRIVE Select System

Karl Storz SE & CO. KG · Sep 18, 2026 · K261102

FDA cleared the UNIDRIVE Select System from Karl Storz SE & CO. KG on Sep 18, 2026 under K261102, a traditional 510(k). The device falls under product code HIH, Hysteroscope (And Accessories), regulated at 21 CFR 884.1690 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Apr 3, 2026. The decision came 168 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K260884 (UNIDRIVE Select System), K254103 (HOPKINS Telescopes for Arthroscopy), K260209 (ENDOFLATOR+; Smart Smoke Evacuation), K261706 (Endomat Select (UP220)).

Questions & Answers

What did FDA clear under K261102?

K261102 is the FDA 510(k) for UNIDRIVE Select System, submitted by Karl Storz SE & CO. KG. FDA's decision date was Sep 18, 2026, under product code HIH (Hysteroscope (And Accessories)).

Who makes the UNIDRIVE Select System?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K261102.

How long did the K261102 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Sep 18, 2026, 168 days later.

← All decisions in September 2026