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FDA 510(k)

CO2 INSUFFLATION TUBING

K-Number: K922038 · 1992-10-13

ApplicantSurgeon Surgical Instrumentation, Inc.
Decision Date1992-10-13
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO2 INSUFFLATION TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1992-10-13 under 510(k) number K922038. 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 CO2 INSUFFLATION TUBING?

CO2 INSUFFLATION TUBING is a medical device that received FDA 510(k) clearance on 1992-10-13. The listed applicant is Surgeon Surgical Instrumentation, Inc.. The 510(k) number is K922038.

When did CO2 INSUFFLATION TUBING receive FDA 510(k) clearance?

CO2 INSUFFLATION TUBING received FDA 510(k) clearance on 1992-10-13, under 510(k) number K922038.

Who is the listed applicant for CO2 INSUFFLATION TUBING?

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

What is the FDA product code for CO2 INSUFFLATION TUBING?

The FDA product code for CO2 INSUFFLATION TUBING is HIF.

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Other records listing Surgeon Surgical Instrumentation, 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.

K954241SURGIN GENISIS PHACOEMULSIFIERK932281VERRES NEEDLEK904010SURGICAL ASPIRATOR KITK890447HEMORRHAGE OCCLUDORK880543UNI-PORTK881232SURGIN EYE SHIELD

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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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