FDA product code PGU: Spatial Imaging For Display Of Endoscope Position
PGU is the FDA product code for spatial imaging for display of endoscope position. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under PGU. The average 510(k) review took 67 days (median 67).
Definition
To detect and display the shape of an inserted endoscope.
Classification
| Field | Value |
|---|---|
| Device name | Spatial Imaging For Display Of Endoscope Position |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PGU clearance
Top PGU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corp. | 1 | 2014-03-07 |
Most recent PGU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K134026 | Olympus Medical Systems Corp. | ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT | 2014-03-07 | 67 |
Recalls for PGU devices
openFDA lists no recalls for product code PGU.
Frequently asked questions
What is FDA product code PGU?
PGU is the FDA product code for spatial imaging for display of endoscope position. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is PGU?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGU?
Across 1 cleared submissions the average was 67 days from receipt to decision (median 67).
Which companies have the most PGU clearances?
Olympus Medical Systems Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PGU
- Run a recall and safety report across every PGU manufacturer
- Watch product code PGU 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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