Cleared Traditional

BAROnova Access Sheath Kit

K191078 · Baronova, Inc. · Gastroenterology & Urology
Jul 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K191078 is an FDA 510(k) clearance for the BAROnova Access Sheath Kit, a Esophageal Sheath With Distal Balloon Anchor (Class II — Special Controls, product code QGG), submitted by Baronova, Inc. (San Carlos, US). The FDA issued a Cleared decision on July 22, 2019, 90 days after receiving the submission on April 23, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1510.

Submission Details

510(k) Number K191078 FDA.gov
FDA Decision Cleared SESK
Date Received April 23, 2019
Decision Date July 22, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code QGG — Esophageal Sheath With Distal Balloon Anchor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1510
Definition 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.