FDA product code QDY: Vitrectomy Kit
QDY is the FDA product code for vitrectomy kit. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel. Devices under QDY 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 | Vitrectomy Kit |
| Device class | Class II |
| Regulation | 21 CFR 886.4150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for QDY devices
openFDA lists no recalls for product code QDY.
Frequently asked questions
What is FDA product code QDY?
QDY is the FDA product code for vitrectomy kit. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel.
What device class is QDY?
Class II, regulation 21 CFR 886.4150. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QDY
- Run a recall and safety report across every QDY manufacturer
- Watch product code QDY 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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