Cleared Traditional

FEATHER-TOUCH SINGLE-STICK DEVICE

K942620 · Ulster Scientific, Inc. · General & Plastic Surgery

Jun 1994

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K942620 is an FDA 510(k) clearance for the FEATHER-TOUCH SINGLE-STICK DEVICE, a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code FMK), submitted by Ulster Scientific, Inc. (New Paltz, US). The FDA issued a Cleared decision on June 22, 1994, 20 days after receiving the submission on June 2, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K942620 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1994
Decision Date	June 22, 1994
Days to Decision	20 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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.