510(k) K231124
K231124 is an FDA 510(k) premarket notification submitted by Owen Mumford, Ltd. for the device "Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)". The FDA issued a decision of Substantially Equivalent on June 27, 2023. 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. Owen Mumford, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2023
- Date Received
- April 20, 2023
- Clearance Type
- Traditional
- 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
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.