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510(k) K191078

BAROnova Access Sheath Kit by Baronova, Inc. — Product Code QGG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 22, 2019
Date Received
April 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophageal Sheath With Distal Balloon Anchor
Device Class
Class II
Regulation Number
876.1510
Review Panel
GU
Submission Type

Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device.

Other clearances by Baronova, Inc.

  • K190985 — BAROnova Insufflation System, BAROnova Accessory Kit (May 14, 2019)
  • K172575 — BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap (January 18, 2018)