Cleared Traditional

B-D PEN ULTRA

K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Jun 1998
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K981797 is an FDA 510(k) clearance for the B-D PEN ULTRA, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 12, 1998, 22 days after receiving the submission on May 21, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K981797 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1998
Decision Date June 12, 1998
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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