Low Dead Space Piston Syringe

QNQ · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5860

Classification

FDA Product Code: QNQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5860
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.

Market data

Cleared 510(k) submissions: 12
Registered establishments: 14

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown