FDA product code PJH: Dynamic Rectal Control System
PJH is the FDA product code for dynamic rectal control system. It is a Class II device, regulated under 21 CFR 876.5930 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under PJH. The average 510(k) review took 253 days (median 253). 1 De Novo request was granted under it.
Definition
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
Classification
| Field | Value |
|---|---|
| Device name | Dynamic Rectal Control System |
| Device class | Class II |
| Regulation | 21 CFR 876.5930 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PJH clearance
Top PJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pelvalon, Inc. | 1 | 2015-11-12 |
Most recent PJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150558 | Pelvalon, Inc. | Eclipse System | 2015-11-12 | 253 |
Recalls for PJH devices
openFDA lists no recalls for product code PJH.
Frequently asked questions
What is FDA product code PJH?
PJH is the FDA product code for dynamic rectal control system. It is a Class II device, regulated under 21 CFR 876.5930 and reviewed by the Gastroenterology and Urology panel.
What device class is PJH?
Class II, regulation 21 CFR 876.5930. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJH?
Across 1 cleared submissions the average was 253 days from receipt to decision (median 253).
Which companies have the most PJH clearances?
Pelvalon, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PJH
- Run a recall and safety report across every PJH manufacturer
- Watch product code PJH 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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