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FDA 510(k)

PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA

K-Number: K132203 · 2013-09-20

ApplicantLexion Medical, LLC
Decision Date2013-09-20
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Lexion Medical, LLC. It received FDA 510(k) clearance on 2013-09-20 under 510(k) number K132203. 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 PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA?

PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA is a medical device that received FDA 510(k) clearance on 2013-09-20. The listed applicant is Lexion Medical, LLC. The 510(k) number is K132203.

When did PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA receive FDA 510(k) clearance?

PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA received FDA 510(k) clearance on 2013-09-20, under 510(k) number K132203.

Who is the listed applicant for PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA?

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

What is the FDA product code for PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA?

The FDA product code for PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA is HIF.

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Other records listing Lexion Medical, LLC 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.

K191780AP50/30 Insufflator with Insuflow PortK170799AP 50/30 Insufflator with Insuflow PortK132204INSUFLOW SYNERGY XL PORTK120640INSUFLOW SYNERGY PORTK112357VESSEL GUARDIANK102136VESSEL GUARDIAN

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Related Devices (Code: HIF)

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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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