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FDA 510(k)

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap

K-Number: K172575 · 2018-01-18

ApplicantBaronova, Inc.
Decision Date2018-01-18
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is a medical device manufactured by Baronova, Inc.. It received FDA 510(k) clearance on 2018-01-18 under approval number K172575. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is a medical device that received FDA 510(k) clearance on 2018-01-18. It is manufactured by Baronova, Inc.. The 510(k) number is K172575.

When was BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap approved by the FDA?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap received FDA 510(k) clearance on 2018-01-18, under approval number K172575.

What company makes BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is manufactured by Baronova, Inc..

What is the FDA product code for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

The FDA product code for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is FED.

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K191078BAROnova Access Sheath Kit K190985BAROnova Insufflation System, BAROnova Accessory Kit PMA P180024IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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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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