Cleared Traditional

SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES

K983858 · Sims Portex, Inc. · Anesthesiology
Jan 1999
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K983858 is an FDA 510(k) clearance for the SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES, a Needle, Spinal, Short Term (Class II — Special Controls, product code MIA), submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on January 29, 1999, 88 days after receiving the submission on November 2, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K983858 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1998
Decision Date January 29, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MIA — Needle, Spinal, Short Term
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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