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FDA 510(k)

INSUFLOW CO2IONSHIELD

K-Number: K090879 · 2009-07-23

ApplicantLexion Medical, LLC
Decision Date2009-07-23
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSUFLOW CO2IONSHIELD 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 2009-07-23 under 510(k) number K090879. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFLOW CO2IONSHIELD?

INSUFLOW CO2IONSHIELD is a medical device that received FDA 510(k) clearance on 2009-07-23. The listed applicant is Lexion Medical, LLC. The 510(k) number is K090879.

When did INSUFLOW CO2IONSHIELD receive FDA 510(k) clearance?

INSUFLOW CO2IONSHIELD received FDA 510(k) clearance on 2009-07-23, under 510(k) number K090879.

Who is the listed applicant for INSUFLOW CO2IONSHIELD?

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 INSUFLOW CO2IONSHIELD?

The FDA product code for INSUFLOW CO2IONSHIELD is FCX.

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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 PortK132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULAK132204INSUFLOW SYNERGY XL PORTK120640INSUFLOW SYNERGY PORTK112357VESSEL GUARDIAN

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Related Devices (Code: FCX)

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.

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 InsufflatorPalliare , Ltd.K202922END 200 Endoscopic TubesetPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.

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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