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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 2025 / K252646

510(k) cleared

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Olympus Medical Systems Corp. · Oct 24, 2025 · K252646

FDA cleared the Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) from Olympus Medical Systems Corp. on Oct 24, 2025 under K252646, a traditional 510(k). The device falls under product code FCG, Biopsy Needle, regulated at 21 CFR 876.1075 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 21, 2025. The decision came 64 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 K252646?

K252646 is the FDA 510(k) for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H), submitted by Olympus Medical Systems Corp.. FDA's decision date was Oct 24, 2025, under product code FCG (Biopsy Needle).

Who makes the Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

Olympus Medical Systems Corp., based in Hachioji-Shi, is the applicant of record for K252646.

How long did the K252646 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Oct 24, 2025, 64 days later.

← All decisions in October 2025