Cleared Traditional

BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757

K020523 · Bd · General Hospital

Mar 2002

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K020523 is an FDA 510(k) clearance for the BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on March 20, 2002, 29 days after receiving the submission on February 19, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K020523 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2002
Decision Date	March 20, 2002
Days to Decision	29 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.