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FDA 510(k)

BAROnova Access Sheath Kit

K-Number: K191078 · 2019-07-22

ApplicantBaronova, Inc.
Decision Date2019-07-22
Product CodeQGG
Advisory CommitteeGU
DecisionUnknown

Device Summary

BAROnova Access Sheath Kit is a medical device manufactured by Baronova, Inc.. It received FDA 510(k) clearance on 2019-07-22 under approval number K191078. The device is classified under product code QGG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BAROnova Access Sheath Kit?

BAROnova Access Sheath Kit is a medical device that received FDA 510(k) clearance on 2019-07-22. It is manufactured by Baronova, Inc.. The 510(k) number is K191078.

When was BAROnova Access Sheath Kit approved by the FDA?

BAROnova Access Sheath Kit received FDA 510(k) clearance on 2019-07-22, under approval number K191078.

What company makes BAROnova Access Sheath Kit?

BAROnova Access Sheath Kit is manufactured by Baronova, Inc..

What is the FDA product code for BAROnova Access Sheath Kit?

The FDA product code for BAROnova Access Sheath Kit is QGG.

Related Clinical Trials

NCT07568990 Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery NOT_YET_RECRUITING NCT06547632 ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach TERMINATED NCT07072598 Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS RECRUITING

Other Devices by Baronova, Inc.

K172575BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap K190985BAROnova Insufflation System, BAROnova Accessory Kit PMA P180024IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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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