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FDA 510(k)

High Flow Insufflation Unit (UHI-4)

K-Number: K243527 · 2025-01-13

ApplicantOlympus Medical Systems Corporation
Decision Date2025-01-13
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

High Flow Insufflation Unit (UHI-4) is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-01-13 under approval number K243527. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the High Flow Insufflation Unit (UHI-4)?

High Flow Insufflation Unit (UHI-4) is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K243527.

When was High Flow Insufflation Unit (UHI-4) approved by the FDA?

High Flow Insufflation Unit (UHI-4) received FDA 510(k) clearance on 2025-01-13, under approval number K243527.

What company makes High Flow Insufflation Unit (UHI-4)?

High Flow Insufflation Unit (UHI-4) is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for High Flow Insufflation Unit (UHI-4)?

The FDA product code for High Flow Insufflation Unit (UHI-4) is HIF.

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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Related Devices (Code: HIF)

K162648U-Blade Veress NeedleTianjin Uwell Medical Device Manufacturing Co., Ltd. K153367S698 Symbioz flowSopro - Acteon Group K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare K171139LaparoLight Veress NeedleBuffalo Filter, LLC

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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