FDA product code PVV: Paracervical Anesthesia Kit
PVV is the FDA product code for paracervical anesthesia kit. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel. Devices under PVV 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 | Paracervical Anesthesia Kit |
| Device class | Class II |
| Regulation | 21 CFR 884.5100 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for PVV devices
openFDA lists no recalls for product code PVV.
Frequently asked questions
What is FDA product code PVV?
PVV is the FDA product code for paracervical anesthesia kit. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel.
What device class is PVV?
Class II, regulation 21 CFR 884.5100. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PVV
- Run a recall and safety report across every PVV manufacturer
- Watch product code PVV 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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