Single-Use Biopsy Valve (MAJ-1555) (K251997): 510(k) cleared Sep 25, 2025

Single-Use Biopsy Valve (MAJ-1555)

Olympus Medical Systems Corporation · Sep 25, 2025 · K251997

FDA cleared the Single-Use Biopsy Valve (MAJ-1555) from Olympus Medical Systems Corporation on Sep 25, 2025 under K251997, a traditional 510(k). The device falls under product code OCX, Endoscopic Irrigation/Suction System, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 27, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Olympus Medical Systems Corporation has 8 other decisions in the tracker over the last 12 months: K261183 (EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)), K254056 (THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)), K261260 (HD Camera Head OLYMPUS CH-S200-08-LB), K260580 (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)).

Questions & Answers

What did FDA clear under K251997?

K251997 is the FDA 510(k) for Single-Use Biopsy Valve (MAJ-1555), submitted by Olympus Medical Systems Corporation. FDA's decision date was Sep 25, 2025, under product code OCX (Endoscopic Irrigation/Suction System).

Who makes the Single-Use Biopsy Valve (MAJ-1555)?

Olympus Medical Systems Corporation, based in Hachioji-Shi, is the applicant of record for K251997.

How long did the K251997 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Sep 25, 2025, 90 days later.

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