FDA product code PPP: Disposable Joint Aspiration/Injection Kit
PPP is the FDA product code for disposable joint aspiration/injection kit. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the Orthopedic panel. Devices under PPP 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 | Disposable Joint Aspiration/Injection Kit |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for PPP devices
openFDA lists no recalls for product code PPP.
Frequently asked questions
What is FDA product code PPP?
PPP is the FDA product code for disposable joint aspiration/injection kit. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the Orthopedic panel.
What device class is PPP?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PPP
- Run a recall and safety report across every PPP manufacturer
- Watch product code PPP 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.