FDA product code PSI: Perineal Irrigation Kit
PSI is the FDA product code for perineal irrigation kit. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Obstetrics and Gynecology panel. Devices under PSI 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 | Perineal Irrigation Kit |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PSI devices
openFDA lists no recalls for product code PSI.
Frequently asked questions
What is FDA product code PSI?
PSI is the FDA product code for perineal irrigation kit. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Obstetrics and Gynecology panel.
What device class is PSI?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PSI
- Run a recall and safety report across every PSI manufacturer
- Watch product code PSI 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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