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FDA 510(k)

INSUFFLATOR TUBING/FILTER KIT

K-Number: K922244 · 1993-09-24

ApplicantO.R. Concepts, Inc.
Decision Date1993-09-24
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATOR TUBING/FILTER KIT is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Concepts, Inc.. It received FDA 510(k) clearance on 1993-09-24 under 510(k) number K922244. 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 TUBING/FILTER KIT?

INSUFFLATOR TUBING/FILTER KIT is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is O.R. Concepts, Inc.. The 510(k) number is K922244.

When did INSUFFLATOR TUBING/FILTER KIT receive FDA 510(k) clearance?

INSUFFLATOR TUBING/FILTER KIT received FDA 510(k) clearance on 1993-09-24, under 510(k) number K922244.

Who is the listed applicant for INSUFFLATOR TUBING/FILTER KIT?

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

What is the FDA product code for INSUFFLATOR TUBING/FILTER KIT?

The FDA product code for INSUFFLATOR TUBING/FILTER KIT is HIF.

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Other records listing O.R. Concepts, 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.

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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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