PGO — Anti-Stick Glass Syringe Class N

FDA Device Classification

FDA product code PGO covers "Anti-Stick Glass Syringe", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
PGO
Device Class
Class N
Regulation Number
Submission Type
Review Panel
HO
Medical Specialty
Unknown
Implant
No

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.