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FDA 510(k)

BAROnova Insufflation System, BAROnova Accessory Kit

K-Number: K190985 · 2019-05-14

ApplicantBaronova, Inc.
Decision Date2019-05-14
Product CodeFCX
Advisory CommitteeGU
DecisionUnknown

Device Summary

BAROnova Insufflation System, BAROnova Accessory Kit is the device name listed in this FDA 510(k) record. The listed applicant is Baronova, Inc.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K190985. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BAROnova Insufflation System, BAROnova Accessory Kit?

BAROnova Insufflation System, BAROnova Accessory Kit is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Baronova, Inc.. The 510(k) number is K190985.

When did BAROnova Insufflation System, BAROnova Accessory Kit receive FDA 510(k) clearance?

BAROnova Insufflation System, BAROnova Accessory Kit received FDA 510(k) clearance on 2019-05-14, under 510(k) number K190985.

Who is the listed applicant for BAROnova Insufflation System, BAROnova Accessory Kit?

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

What is the FDA product code for BAROnova Insufflation System, BAROnova Accessory Kit?

The FDA product code for BAROnova Insufflation System, BAROnova Accessory Kit is FCX.

Other records listing Baronova, 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.

K191078BAROnova Access Sheath KitPMA P180024IMPLANT, INTRAGASTRIC FOR MORBID OBESITYK172575BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap

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.K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm 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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