FDA product code QDW: Phaco Kit
QDW is the FDA product code for phaco kit. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel. Devices under QDW 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 | Phaco Kit |
| Device class | Class II |
| Regulation | 21 CFR 886.4670 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for QDW devices
openFDA lists no recalls for product code QDW.
Frequently asked questions
What is FDA product code QDW?
QDW is the FDA product code for phaco kit. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel.
What device class is QDW?
Class II, regulation 21 CFR 886.4670. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QDW
- Run a recall and safety report across every QDW manufacturer
- Watch product code QDW 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.