510(k) K191078
K191078 is an FDA 510(k) premarket notification submitted by Baronova, Inc. for the device "BAROnova Access Sheath Kit". The FDA issued a decision of Substantially Equivalent - Kit on Jul 22, 2019. The device falls under product code QGG (Esophageal Sheath With Distal Balloon Anchor), a Class II device regulated under 21 CFR 876.1510. Baronova, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Jul 22, 2019
- Date Received
- Apr 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal Sheath With Distal Balloon Anchor
- Device Class
- Class II
- Regulation Number
- 876.1510
- Review Panel
- GU
- Submission Type
- 510(k)
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.