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FDA 510(k)

INSUFFLATOR

K-Number: K812200 · 1981-09-29

ApplicantReznik Instruments
Decision Date1981-09-29
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Reznik Instruments. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812200. 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 INSUFFLATOR?

INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Reznik Instruments. The 510(k) number is K812200.

When did INSUFFLATOR receive FDA 510(k) clearance?

INSUFFLATOR received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812200.

Who is the listed applicant for INSUFFLATOR?

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

What is the FDA product code for INSUFFLATOR?

The FDA product code for INSUFFLATOR is HIF.

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Other records listing Reznik Instruments 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.

K812205FORCEPK812201PHOTOGRAPHIC EQUIPMENTK812204UTERINE MANIPULATORSK812203ELECTROSURGICAL UNITK812199TROCAR & TROCAR SLEEVESK812206LAPAROSCOPE

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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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