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FDA 510(k)

AUXILIARY WATER TUBE MAJ-855

K-Number: K251986 · 2025-09-26

ApplicantOlympus Medical Systems Corporation
Decision Date2025-09-26
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUXILIARY WATER TUBE MAJ-855 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 2025-09-26 under 510(k) number K251986. 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 AUXILIARY WATER TUBE MAJ-855?

AUXILIARY WATER TUBE MAJ-855 is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251986.

When did AUXILIARY WATER TUBE MAJ-855 receive FDA 510(k) clearance?

AUXILIARY WATER TUBE MAJ-855 received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251986.

Who is the listed applicant for AUXILIARY WATER TUBE MAJ-855?

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 AUXILIARY WATER TUBE MAJ-855?

The FDA product code for AUXILIARY WATER TUBE MAJ-855 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.

K251997Single-Use Biopsy Valve (MAJ-1555)Olympus 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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