FDA product code PSJ: Rectal Dilator Kit
PSJ is the FDA product code for rectal dilator kit. It is a Class I device, regulated under 21 CFR 876.5450 and reviewed by the Gastroenterology and Urology panel. Devices under PSJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Rectal Dilator Kit |
| Device class | Class I |
| Regulation | 21 CFR 876.5450 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PSJ devices
openFDA lists no recalls for product code PSJ.
Frequently asked questions
What is FDA product code PSJ?
PSJ is the FDA product code for rectal dilator kit. It is a Class I device, regulated under 21 CFR 876.5450 and reviewed by the Gastroenterology and Urology panel.
What device class is PSJ?
Class I, regulation 21 CFR 876.5450. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PSJ
- Run a recall and safety report across every PSJ manufacturer
- Watch product code PSJ 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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