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FDA 510(k)

SURGIFLATOR-30

K-Number: K973432 · 1997-12-09

ApplicantW.O.M. World of Medicine GmbH
Decision Date1997-12-09
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURGIFLATOR-30 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 1997-12-09 under 510(k) number K973432. 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 SURGIFLATOR-30?

SURGIFLATOR-30 is a medical device that received FDA 510(k) clearance on 1997-12-09. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K973432.

When did SURGIFLATOR-30 receive FDA 510(k) clearance?

SURGIFLATOR-30 received FDA 510(k) clearance on 1997-12-09, under 510(k) number K973432.

Who is the listed applicant for SURGIFLATOR-30?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIFLATOR-30?

The FDA product code for SURGIFLATOR-30 is HIF.

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Other records listing W.O.M. World of Medicine GmbH as applicant

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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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