Cleared Traditional

NEONATAL UNILET

K861243 · Ulster Scientific, Inc. · General & Plastic Surgery

Apr 1986

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K861243 is an FDA 510(k) clearance for the NEONATAL UNILET, 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. (Highland, US). The FDA issued a Cleared decision on April 29, 1986, 27 days after receiving the submission on April 2, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K861243 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 1986
Decision Date	April 29, 1986
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

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.