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FDA 510(k)

ENDOGATER AVANTAGE CO2 INSUFFLATOR

K-Number: K113310 · 2012-06-20

ApplicantByrne Medical, Inc.
Decision Date2012-06-20
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOGATER AVANTAGE CO2 INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Byrne Medical, Inc.. It received FDA 510(k) clearance on 2012-06-20 under 510(k) number K113310. 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 ENDOGATER AVANTAGE CO2 INSUFFLATOR?

ENDOGATER AVANTAGE CO2 INSUFFLATOR is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K113310.

When did ENDOGATER AVANTAGE CO2 INSUFFLATOR receive FDA 510(k) clearance?

ENDOGATER AVANTAGE CO2 INSUFFLATOR received FDA 510(k) clearance on 2012-06-20, under 510(k) number K113310.

Who is the listed applicant for ENDOGATER AVANTAGE CO2 INSUFFLATOR?

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

What is the FDA product code for ENDOGATER AVANTAGE CO2 INSUFFLATOR?

The FDA product code for ENDOGATER AVANTAGE CO2 INSUFFLATOR is FCX.

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Other records listing Byrne 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.

K113119ENDOGATOR ADVANTAGE IRRIGATION PUMPK102855UNIVERSAL IRRIGATION SOLUTION HYBRIDK102581DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305K102409DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304K093665ENDO SMARTCAPK092090ERBELIFT HAND PUMP AND FLEXIBLE PROBE

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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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