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FDA 510(k)

DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900

K-Number: K921963 · 1992-09-11

ApplicantSun Medical, Inc.
Decision Date1992-09-11
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 is the device name listed in this FDA 510(k) record. The listed applicant is Sun Medical, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K921963. 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 DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900?

DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Sun Medical, Inc.. The 510(k) number is K921963.

When did DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 receive FDA 510(k) clearance?

DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 received FDA 510(k) clearance on 1992-09-11, under 510(k) number K921963.

Who is the listed applicant for DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900?

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

What is the FDA product code for DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900?

The FDA product code for DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 is HIF.

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Other records listing Sun Medical, 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.

K911154SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200K874948SUN MEDICAL SMOKE EVACUATOR SYSTEMK845006SUN MEDICAL LAMINARIA CERVICAL DILATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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