Cleared Traditional

BAROnova Insufflation System, BAROnova Accessory Kit

K190985 · Baronova, Inc. · Gastroenterology & Urology
May 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K190985 is an FDA 510(k) clearance for the BAROnova Insufflation System, BAROnova Accessory Kit, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by Baronova, Inc. (San Carlos, US). The FDA issued a Cleared decision on May 14, 2019, 29 days after receiving the submission on April 15, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K190985 FDA.gov
FDA Decision Cleared SESK
Date Received April 15, 2019
Decision Date May 14, 2019
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCX — Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500