Cleared Special

BD ECLIPSE BIFURCATED NEEDLE

K032528 · Becton, Dickinson & CO · General Hospital

Sep 2003

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K032528 is an FDA 510(k) clearance for the BD ECLIPSE BIFURCATED NEEDLE, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on September 9, 2003, 25 days after receiving the submission on August 15, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K032528 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2003
Decision Date	September 09, 2003
Days to Decision	25 days
Submission Type	Special
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.