FDA 510(k)

BAROnova Access Sheath Kit

K-Number: K191078 · 2019-07-22

Decision Date2019-07-22

Product CodeQGG

Advisory CommitteeGU

DecisionUnknown

Device Summary

BAROnova Access Sheath 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 2019-07-22 under 510(k) 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. The listed applicant is Baronova, Inc.. The 510(k) number is K191078.

When did BAROnova Access Sheath Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for BAROnova Access Sheath 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 Access Sheath Kit?

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

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.

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

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.