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FDA 510(k)

HIGH FLOW INSUFFLANTION UNIT

K-Number: K122180 · 2012-11-13

ApplicantOlympus Medical Systems Corporation
Decision Date2012-11-13
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HIGH FLOW INSUFFLANTION UNIT 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 2012-11-13 under 510(k) number K122180. 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 INSUFFLANTION UNIT?

HIGH FLOW INSUFFLANTION UNIT is a medical device that received FDA 510(k) clearance on 2012-11-13. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K122180.

When did HIGH FLOW INSUFFLANTION UNIT receive FDA 510(k) clearance?

HIGH FLOW INSUFFLANTION UNIT received FDA 510(k) clearance on 2012-11-13, under 510(k) number K122180.

Who is the listed applicant for HIGH FLOW INSUFFLANTION UNIT?

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 HIGH FLOW INSUFFLANTION UNIT?

The FDA product code for HIGH FLOW INSUFFLANTION UNIT is HIF.

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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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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