Cleared Traditional

B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16

K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Nov 2000
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K002938 is an FDA 510(k) clearance for the B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on November 29, 2000, 69 days after receiving the submission on September 21, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K002938 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2000
Decision Date November 29, 2000
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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