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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 / March 2026 / K251807

510(k) cleared

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

Olympus Medical Systems Corp. · Mar 6, 2026 · K251807

FDA cleared the Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR from Olympus Medical Systems Corp. on Mar 6, 2026 under K251807, a traditional 510(k). The device falls under product code KGE, Forceps, Biopsy, Electric, regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 12, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K251807?

K251807 is the FDA 510(k) for Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR, submitted by Olympus Medical Systems Corp.. FDA's decision date was Mar 6, 2026, under product code KGE (Forceps, Biopsy, Electric).

Who makes the Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR?

Olympus Medical Systems Corp., based in Hachioji-Shi, is the applicant of record for K251807.

How long did the K251807 review take?

FDA received the submission on Jun 12, 2025 and issued its decision on Mar 6, 2026, 267 days later.

← All decisions in March 2026