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FDA 510(k)

LAPAROFLATOR ELECTRONIC 3509

K-Number: K910883 · 1991-03-29

ApplicantF.M. Wiest USA, Inc.
Decision Date1991-03-29
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROFLATOR ELECTRONIC 3509 is the device name listed in this FDA 510(k) record. The listed applicant is F.M. Wiest USA, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910883. 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 LAPAROFLATOR ELECTRONIC 3509?

LAPAROFLATOR ELECTRONIC 3509 is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is F.M. Wiest USA, Inc.. The 510(k) number is K910883.

When did LAPAROFLATOR ELECTRONIC 3509 receive FDA 510(k) clearance?

LAPAROFLATOR ELECTRONIC 3509 received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910883.

Who is the listed applicant for LAPAROFLATOR ELECTRONIC 3509?

The FDA 510(k) record lists F.M. Wiest USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROFLATOR ELECTRONIC 3509?

The FDA product code for LAPAROFLATOR ELECTRONIC 3509 is HIF.

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Other records listing F.M. Wiest USA, 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.

K921871HYSTEROMAT(TM) 3700K920574CAMSYS 6300K920575MERKUR 4000K915751URETEROMAT 4400K911844HYSTEROFLATOR 1500K912071SPACE(TM) 7500

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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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