Cleared Traditional

BIFURCATED VACCINATING NEEDLE

K012515 · Precision Medical Products, Inc. · General Hospital

Sep 2001

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K012515 is an FDA 510(k) clearance for the BIFURCATED VACCINATING NEEDLE, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Precision Medical Products, Inc. (Denver, US). The FDA issued a Cleared decision on September 19, 2001, 44 days after receiving the submission on August 6, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K012515 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2001
Decision Date	September 19, 2001
Days to Decision	44 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	SCL — Allergen And Vaccine Delivery Needles
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.