510(k) K101145
K101145 is an FDA 510(k) premarket notification submitted by Medipurpose Pte. , Ltd. for the device "SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250". The FDA issued a decision of Substantially Equivalent on Oct 21, 2010. The device falls under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. Medipurpose Pte. , Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2010
- Date Received
- Apr 23, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
- 510(k)
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.