FDA product code PZG: Surgical Eye Tray
PZG is the FDA product code for surgical eye tray. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. Devices under PZG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 6 recalls for PZG devices, 6 initiated in the last five years.
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 | Surgical Eye Tray |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for PZG devices
6 product recalls in 1 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2021-11-17.
| Year | Recalls |
|---|---|
| 2021 | 6 |
Frequently asked questions
What is FDA product code PZG?
PZG is the FDA product code for surgical eye tray. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is PZG?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
Have PZG devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2021-11-17.
Next steps
- Run an FDA pathway report with predicate devices for product code PZG
- Run a recall and safety report across every PZG manufacturer
- Watch product code PZG 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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