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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 / May 2026 / K260423

510(k) cleared

Disposable Endoscopic Distal Attachments

Yangzhou Fartley Medical Instrument Technology Co., Ltd. · May 28, 2026 · K260423

FDA cleared the Disposable Endoscopic Distal Attachments from Yangzhou Fartley Medical Instrument Technology Co., Ltd. on May 28, 2026 under K260423, a traditional 510(k). The device falls under product code FDF, Colonoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 9, 2026. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Yangzhou Fartley Medical Instrument Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260512 (Disposable Ureteral Access Sheath).

Questions & Answers

What did FDA clear under K260423?

K260423 is the FDA 510(k) for Disposable Endoscopic Distal Attachments, submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. FDA's decision date was May 28, 2026, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the Disposable Endoscopic Distal Attachments?

Yangzhou Fartley Medical Instrument Technology Co., Ltd., based in Yangzhou, is the applicant of record for K260423.

How long did the K260423 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on May 28, 2026, 108 days later.

← All decisions in May 2026

Sources