FDA product code NGU: Balloon, Liver Tamponade
NGU is the FDA product code for balloon, liver tamponade. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NGU. The average 510(k) review took 203 days (median 203).
Classification
| Field | Value |
|---|---|
| Device name | Balloon, Liver Tamponade |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NGU clearance
Top NGU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook, Inc. | 1 | 2001-09-06 |
Most recent NGU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010450 | Cook, Inc. | LIVER TAMPONADE BALLOON | 2001-09-06 | 203 |
Recalls for NGU devices
openFDA lists no recalls for product code NGU.
Frequently asked questions
What is FDA product code NGU?
NGU is the FDA product code for balloon, liver tamponade. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the General and Plastic Surgery panel.
What device class is NGU?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGU?
Across 1 cleared submissions the average was 203 days from receipt to decision (median 203).
Which companies have the most NGU clearances?
Cook, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NGU
- Run a recall and safety report across every NGU manufacturer
- Watch product code NGU 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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