FDA product code PRU: Gastric Lavage Kit (Adult Or Pediatric Use)
PRU is the FDA product code for gastric lavage kit (adult or pediatric use). It is a Class II device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel. Devices under PRU 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 | Gastric Lavage Kit (Adult Or Pediatric Use) |
| Device class | Class II |
| Regulation | 21 CFR 876.4370 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PRU devices
openFDA lists no recalls for product code PRU.
Frequently asked questions
What is FDA product code PRU?
PRU is the FDA product code for gastric lavage kit (adult or pediatric use). It is a Class II device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel.
What device class is PRU?
Class II, regulation 21 CFR 876.4370. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PRU
- Run a recall and safety report across every PRU manufacturer
- Watch product code PRU 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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