QGG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Esophageal Sheath With Distal Balloon Anchor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1510
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BAROnova Access Sheath Kit (K191078) | Baronova, Inc. | 2019-07-22 |
Track QGG automatically
Every clearance here is in the API, with alerts when new ones post.