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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 / July 2026 / K261706

510(k) cleared

Endomat Select (UP220)

KARL STORZ SE & CO. KG · Jul 16, 2026 · K261706

FDA cleared the Endomat Select (UP220) from KARL STORZ SE & CO. KG on Jul 16, 2026 under K261706, a traditional 510(k). The device falls under product code HIG, Insufflator, Hysteroscopic, regulated at 21 CFR 884.1700 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on May 22, 2026. The decision came 55 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 K261706?

K261706 is the FDA 510(k) for Endomat Select (UP220), submitted by KARL STORZ SE & CO. KG. FDA's decision date was Jul 16, 2026, under product code HIG (Insufflator, Hysteroscopic).

Who makes the Endomat Select (UP220)?

KARL STORZ SE & CO. KG, based in Tuttlingen, is the applicant of record for K261706.

How long did the K261706 review take?

FDA received the submission on May 22, 2026 and issued its decision on Jul 16, 2026, 55 days later.

← All decisions in July 2026