FDA product code QGG: Esophageal Sheath With Distal Balloon Anchor
QGG is the FDA product code for esophageal sheath with distal balloon anchor. It is a Class II device, regulated under 21 CFR 876.1510 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QGG. The average 510(k) review took 90 days (median 90).
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.
Classification
| Field | Value |
|---|---|
| Device name | Esophageal Sheath With Distal Balloon Anchor |
| Device class | Class II |
| Regulation | 21 CFR 876.1510 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QGG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
Top QGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baronova, Inc. | 1 | 2019-07-22 |
Most recent QGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191078 | Baronova, Inc. | BAROnova Access Sheath Kit | 2019-07-22 | 90 |
Recalls for QGG devices
openFDA lists no recalls for product code QGG.
Frequently asked questions
What is FDA product code QGG?
QGG is the FDA product code for esophageal sheath with distal balloon anchor. It is a Class II device, regulated under 21 CFR 876.1510 and reviewed by the Gastroenterology and Urology panel.
What device class is QGG?
Class II, regulation 21 CFR 876.1510. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGG?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most QGG clearances?
Baronova, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGG
- Run a recall and safety report across every QGG manufacturer
- Watch product code QGG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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