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FDA 510(k)

ELECTRONIC INSUFFLATOR MODEL 2054.61

K-Number: K921756 · 1994-03-28

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1994-03-28
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC INSUFFLATOR MODEL 2054.61 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K921756. 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 ELECTRONIC INSUFFLATOR MODEL 2054.61?

ELECTRONIC INSUFFLATOR MODEL 2054.61 is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K921756.

When did ELECTRONIC INSUFFLATOR MODEL 2054.61 receive FDA 510(k) clearance?

ELECTRONIC INSUFFLATOR MODEL 2054.61 received FDA 510(k) clearance on 1994-03-28, under 510(k) number K921756.

Who is the listed applicant for ELECTRONIC INSUFFLATOR MODEL 2054.61?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRONIC INSUFFLATOR MODEL 2054.61?

The FDA product code for ELECTRONIC INSUFFLATOR MODEL 2054.61 is HIF.

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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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