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510(k) K172575

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap by Baronova, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2018
Date Received
August 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances by Baronova, Inc.

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  • K190985 — BAROnova Insufflation System, BAROnova Accessory Kit (May 14, 2019)

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