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FDA 510(k)

LAP 3501 HIGH FLOW INSUFFLATOR

K-Number: K905705 · 1991-02-28

ApplicantCircon Acmi
Decision Date1991-02-28
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAP 3501 HIGH FLOW INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Circon Acmi. It received FDA 510(k) clearance on 1991-02-28 under 510(k) number K905705. 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 LAP 3501 HIGH FLOW INSUFFLATOR?

LAP 3501 HIGH FLOW INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1991-02-28. The listed applicant is Circon Acmi. The 510(k) number is K905705.

When did LAP 3501 HIGH FLOW INSUFFLATOR receive FDA 510(k) clearance?

LAP 3501 HIGH FLOW INSUFFLATOR received FDA 510(k) clearance on 1991-02-28, under 510(k) number K905705.

Who is the listed applicant for LAP 3501 HIGH FLOW INSUFFLATOR?

The FDA 510(k) record lists Circon Acmi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAP 3501 HIGH FLOW INSUFFLATOR?

The FDA product code for LAP 3501 HIGH FLOW INSUFFLATOR is HIF.

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Other records listing Circon Acmi 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.

K013165USA SERIES LAPAROSCOPESK980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)K905706GYN-1500 HYSTEROSCOPIC INUFFLATORK884097MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPESK884025CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200K884254CIRCON ACMI BICAP III THERAPEUTIC SYSTEM

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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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