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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 a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-09-26 under approval 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. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K251986.

When was AUXILIARY WATER TUBE MAJ-855 approved by the FDA?

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

What company makes AUXILIARY WATER TUBE MAJ-855?

AUXILIARY WATER TUBE MAJ-855 is manufactured by Olympus Medical Systems Corporation.

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 Devices by Olympus Medical Systems Corporation

K211838Ultrasonic Bipolar Generator USG-410 with accessories K221557Visera Hysterovideoscope Olympus HYF Type V K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) K242357Water Container (MAJ-901); Water Container (MAJ-902)

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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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