# K191078: BAROnova Access Sheath Kit

- Pathway: 510(k) (Traditional)
- Applicant: Baronova, Inc.
- Decided: Jul 22, 2019 after 90 days
- Product code: QGG (Esophageal Sheath With Distal Balloon Anchor)
- Device class: 2
- Regulation: 21 CFR 876.1510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K853585 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181451: Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R, Olympus Medical Systems Corp. (2019) Summary page 4.
- K172575: BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap, Baronova, Inc. (2018) Summary page 4.
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 4.

## Indications for use
The BAROnova Access Sheath Kit is used in conjunction with an endoscope for procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract, with or without instruments through the instrument channel of the endoscope. The BAROnova Access Sheath Kit is used in conjunction with the TransPyloric Shuttle Delivery Device to facilitate insertion and positioning of the device during TPS delivery and deployment. The Access Sheath Kit is NOT indicated for foreign body removal or instrument use alongside the endoscope.

Source page: https://510kreport.com/device/K191078
Methodology: https://510kreport.com/methodology