Low Dead Space Needle, Single Lumen, Hypodermic

QNS · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5570

Classification

FDA Product Code: QNS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5570
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 single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 4

Source

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