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FDA 510(k)

Single-Use Biopsy Valve (MAJ-1555)

K-Number: K251997 · 2025-09-25

ApplicantOlympus Medical Systems Corporation
Decision Date2025-09-25
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-Use Biopsy Valve (MAJ-1555) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251997. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-Use Biopsy Valve (MAJ-1555)?

Single-Use Biopsy Valve (MAJ-1555) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251997.

When did Single-Use Biopsy Valve (MAJ-1555) receive FDA 510(k) clearance?

Single-Use Biopsy Valve (MAJ-1555) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251997.

Who is the listed applicant for Single-Use Biopsy Valve (MAJ-1555)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Biopsy Valve (MAJ-1555)?

The FDA product code for Single-Use Biopsy Valve (MAJ-1555) is OCX.

Other records listing Olympus Medical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 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)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single 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)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 112 devices →

Related Devices (Code: OCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.K242134ClearCap Distal AttachmentFinemedix Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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