FDA product code PVL: Endoscopic Shunt Placement Kit
PVL is the FDA product code for endoscopic shunt placement kit. It is a Class II device, regulated under 21 CFR 882.5550 and reviewed by the Neurology panel. Devices under PVL 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 | Endoscopic Shunt Placement Kit |
| Device class | Class II |
| Regulation | 21 CFR 882.5550 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for PVL devices
openFDA lists no recalls for product code PVL.
Frequently asked questions
What is FDA product code PVL?
PVL is the FDA product code for endoscopic shunt placement kit. It is a Class II device, regulated under 21 CFR 882.5550 and reviewed by the Neurology panel.
What device class is PVL?
Class II, regulation 21 CFR 882.5550. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PVL
- Run a recall and safety report across every PVL manufacturer
- Watch product code PVL 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.