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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 / K260580

510(k) cleared

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

Olympus Medical Systems Corp. · May 21, 2026 · K260580

FDA cleared the Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) from Olympus Medical Systems Corp. on May 21, 2026 under K260580, 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 20, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Olympus Medical Systems Corp. has 8 other decisions in the tracker over the last 12 months: K262079 (4K Camera Head OLYMPUS CH-S700-08-LB), K260401 (EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)), K260824 (Gastrointestinal Videoscope Olympus GIF-2T1500), K260856 (Disposable Distal Attachment D-201-13404).

Questions & Answers

What did FDA clear under K260580?

K260580 is the FDA 510(k) for Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS), submitted by Olympus Medical Systems Corp.. FDA's decision date was May 21, 2026, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)?

Olympus Medical Systems Corp., based in Hachioji-Shi, is the applicant of record for K260580.

How long did the K260580 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on May 21, 2026, 90 days later.

← All decisions in May 2026