K190985 is an FDA 510(k) clearance for the BAROnova Insufflation System, BAROnova Accessory Kit. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K190985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (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 |
| Product Code | FCX - Insufflator, Automatic Carbon-dioxide For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |