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FDA 510(k)

LM- LAP 10 HIGH FLOW INSUFFLATOR

K-Number: K914201 · 1992-01-09

ApplicantLeisegang Medical, Inc.
Decision Date1992-01-09
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LM- LAP 10 HIGH FLOW INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Leisegang Medical, Inc.. It received FDA 510(k) clearance on 1992-01-09 under 510(k) number K914201. 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 LM- LAP 10 HIGH FLOW INSUFFLATOR?

LM- LAP 10 HIGH FLOW INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Leisegang Medical, Inc.. The 510(k) number is K914201.

When did LM- LAP 10 HIGH FLOW INSUFFLATOR receive FDA 510(k) clearance?

LM- LAP 10 HIGH FLOW INSUFFLATOR received FDA 510(k) clearance on 1992-01-09, under 510(k) number K914201.

Who is the listed applicant for LM- LAP 10 HIGH FLOW INSUFFLATOR?

The FDA 510(k) record lists Leisegang Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LM- LAP 10 HIGH FLOW INSUFFLATOR?

The FDA product code for LM- LAP 10 HIGH FLOW INSUFFLATOR is HIF.

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Other records listing Leisegang Medical, Inc. 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.

K990043SMOOTHLASE ALEXANDRITE LASER SYSTEMK940094COLPOSCOPES AND ACCESSORIESK924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSK920217MAX-E-VACK912789LM-100/200LOW FLOW INSUFFLATORK913135LM-300TWIN

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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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