FDA product code PGO: Anti-Stick Glass Syringe
PGO is the FDA product code for anti-stick glass syringe. It is a Not classified device, reviewed by the General Hospital panel. Devices under PGO reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Single use devices that are indicated for use as an accessory with sterile 1ML long staked needle prefilled ISO standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject, doctor prescribed medications, and individuals that assist self-injecting patients from accidental needle sticks. Can be used on a wide range of patients including children and adults.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Stick Glass Syringe |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PGO devices
openFDA lists no recalls for product code PGO.
Frequently asked questions
What is FDA product code PGO?
PGO is the FDA product code for anti-stick glass syringe. It is a Not classified device, reviewed by the General Hospital panel.
What device class is PGO?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PGO
- Run a recall and safety report across every PGO manufacturer
- Watch product code PGO 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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