Vacuum Syringe

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

Classification

FDA Product Code: PUR
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

The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 9

Source

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