FDA product code PGD: Colon Capsule Imaging System
PGD is the FDA product code for colon capsule imaging system. It is a Class II device, regulated under 21 CFR 876.1330 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under PGD. The average 510(k) review took 44 days (median 44). 1 De Novo request was granted under it.
Definition
visualization of the colon for the detection of polyps
Classification
| Field | Value |
|---|---|
| Device name | Colon Capsule Imaging System |
| Device class | Class II |
| Regulation | 21 CFR 876.1330 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PGD clearance
Top PGD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Given Imaging , Ltd. | 1 | 2016-01-14 |
Most recent PGD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153466 | Given Imaging , Ltd. | PillCam COLON 2 Capsule Endoscopy System | 2016-01-14 | 44 |
Recalls for PGD devices
openFDA lists no recalls for product code PGD.
Frequently asked questions
What is FDA product code PGD?
PGD is the FDA product code for colon capsule imaging system. It is a Class II device, regulated under 21 CFR 876.1330 and reviewed by the Gastroenterology and Urology panel.
What device class is PGD?
Class II, regulation 21 CFR 876.1330. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGD?
Across 1 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most PGD clearances?
Given Imaging , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PGD
- Run a recall and safety report across every PGD manufacturer
- Watch product code PGD 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times