QGG — Esophageal Sheath With Distal Balloon Anchor Class II
FDA product code QGG covers "Esophageal Sheath With Distal Balloon Anchor", a Class II medical device regulated under 21 CFR 876.1510. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QGG
- Device Class
- Class II
- Regulation Number
- 876.1510
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191078 | Baronova | BAROnova Access Sheath Kit | Jul 22, 2019 |