510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191078Unknown

BAROnova Access Sheath Kit

Baronova, Inc., San Carlos CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191078 is the FDA 510(k) clearance record for BAROnova Access Sheath Kit, a class II device, cleared for Baronova, Inc. on under FDA product code QGG (Esophageal Sheath With Distal Balloon Anchor). FDA's definition for product code QGG reads: "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...". FDA records list 3 510(k) clearances for Baronova, Inc., from to . As of , FDA records show no recalls naming K191078.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QGG Esophageal Sheath With Distal Balloon Anchor
Regulation
21 CFR 876.1510
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baronova, Inc. 1551 Industrial Rd., San Carlos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QGG

Trailing 12 months

FDA records hold no clearances under product code QGG in the trailing twelve months.

FDA records show no clearances under product code QGG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QGG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260