Esophageal Sheath With Distal Balloon Anchor
QGG is the FDA product code for Esophageal Sheath With Distal Balloon Anchor, a class II device type, regulated under 21 CFR 876.1510. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QGG
- Device name
- Esophageal Sheath With Distal Balloon Anchor
- 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.
- Regulation
- 21 CFR 876.1510
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QGG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 1 |
Applicants with the most clearances
Product code QGG| Applicant | Clearances |
|---|---|
| Baronova, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QGG.
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