K191078 is an FDA 510(k) clearance for the BAROnova Access Sheath Kit. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.1510. 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..
| 510(k) Number | K191078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (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 |
| 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. |