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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 / K261741

510(k) cleared

Hemostatic Clip

Anrei Medical (Hz) Co., Ltd. · Oct 2, 2026 · K261741

FDA cleared the Hemostatic Clip from Anrei Medical (Hz) Co., Ltd. on Oct 2, 2026 under K261741, 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 27, 2026. The decision came 128 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 Anrei Medical (Hz) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261741?

K261741 is the FDA 510(k) for Hemostatic Clip, submitted by Anrei Medical (Hz) Co., Ltd.. FDA's decision date was Oct 2, 2026, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the Hemostatic Clip?

Anrei Medical (Hz) Co., Ltd., based in Hangzhou, is the applicant of record for K261741.

How long did the K261741 review take?

FDA received the submission on May 27, 2026 and issued its decision on Oct 2, 2026, 128 days later.

← All decisions in October 2026