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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 / K260156

510(k) cleared

TruVision Single-Use 1.9mm Arthroscopy System

Nexus CMF, LLC · Oct 9, 2026 · K260156

FDA cleared the TruVision Single-Use 1.9mm Arthroscopy System from Nexus CMF, LLC on Oct 9, 2026 under K260156, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 20, 2026. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nexus CMF, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260156?

K260156 is the FDA 510(k) for TruVision Single-Use 1.9mm Arthroscopy System, submitted by Nexus CMF, LLC. FDA's decision date was Oct 9, 2026, under product code HRX (Arthroscope).

Who makes the TruVision Single-Use 1.9mm Arthroscopy System?

Nexus CMF, LLC, based in Salt Lake City, UT, is the applicant of record for K260156.

How long did the K260156 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Oct 9, 2026, 262 days later.

← All decisions in October 2026