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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 / December 2025 / K251562

510(k) cleared

OTSCneo System Set (100.03n-14n, 100.27n-31n)

Ovesco Endoscopy AG · Dec 18, 2025 · K251562

FDA cleared the OTSCneo System Set (100.03n-14n, 100.27n-31n) from Ovesco Endoscopy AG on Dec 18, 2025 under K251562, a traditional 510(k). The device falls under product code PKL, Hemostatic Metal Clip For The Gi Tract, regulated at 21 CFR 876.4400 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 22, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ovesco Endoscopy AG has 2 other decisions in the tracker over the last 12 months: K260487 (stentFIX System Set (100.50n)), K253481 (colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)).

Questions & Answers

What did FDA clear under K251562?

K251562 is the FDA 510(k) for OTSCneo System Set (100.03n-14n, 100.27n-31n), submitted by Ovesco Endoscopy AG. FDA's decision date was Dec 18, 2025, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the OTSCneo System Set (100.03n-14n, 100.27n-31n)?

Ovesco Endoscopy AG, based in Tuebingen, is the applicant of record for K251562.

How long did the K251562 review take?

FDA received the submission on May 22, 2025 and issued its decision on Dec 18, 2025, 210 days later.

← All decisions in December 2025

Sources