Cleared Traditional

Unistik? 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

K231124 · Owen Mumford, Ltd. · General & Plastic Surgery

Jun 2023

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K231124 is an FDA 510(k) clearance for the Unistik? 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G), a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code FMK), submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on June 27, 2023, 68 days after receiving the submission on April 20, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K231124 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2023
Decision Date	June 27, 2023
Days to Decision	68 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4850
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.