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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 a medical device manufactured by Baronova, Inc.. It received FDA 510(k) clearance on 2019-05-14 under approval 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. It is manufactured by Baronova, Inc.. The 510(k) number is K190985.

When was BAROnova Insufflation System, BAROnova Accessory Kit approved by the FDA?

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

What company makes BAROnova Insufflation System, BAROnova Accessory Kit?

BAROnova Insufflation System, BAROnova Accessory Kit is manufactured by Baronova, Inc..

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.

Related Clinical Trials

NCT03418402 Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System COMPLETED NCT05399537 Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT RECRUITING NCT06119087 Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study ACTIVE_NOT_RECRUITING NCT04849884 To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. ACTIVE_NOT_RECRUITING

Other Devices by Baronova, Inc.

K172575BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap K191078BAROnova Access Sheath Kit PMA P180024IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Related Devices (Code: FCX)

K162332Nexcore GI InsufflatorNexcore Technology, LLC K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. K202922END 200 Endoscopic TubesetPalliare , Ltd. K230474EVA5 InsufflatorPalliare , Ltd. K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.

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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