Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

QRK · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4850

Classification

FDA Product Code: QRK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4850
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Market data

Cleared 510(k) submissions: 15
Registered establishments: 79

Source

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