Non-Stainless Steel Needle

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

Classification

FDA Product Code: PVZ
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: Y

Definition

A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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