Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
FMK · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4850
Classification
FDA Product Code
FMK
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, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.