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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 / October 2026 / K260487

510(k) cleared

stentFIX System Set (100.50n)

Ovesco Endoscopy AG · Oct 2, 2026 · K260487

FDA cleared the stentFIX System Set (100.50n) from Ovesco Endoscopy AG on Oct 2, 2026 under K260487, 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 Feb 13, 2026. The decision came 231 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: K253481 (colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)), K251562 (OTSCneo System Set (100.03n-14n, 100.27n-31n)).

Questions & Answers

What did FDA clear under K260487?

K260487 is the FDA 510(k) for stentFIX System Set (100.50n), submitted by Ovesco Endoscopy AG. FDA's decision date was Oct 2, 2026, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the stentFIX System Set (100.50n)?

Ovesco Endoscopy AG, based in Tuebingen, is the applicant of record for K260487.

How long did the K260487 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Oct 2, 2026, 231 days later.

← All decisions in October 2026

Sources