Cleared Traditional

Remington Medical Inc. Tuohy Epidural Needles

K150266 · Remington Medical, Inc. · Anesthesiology
Jun 2015
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K150266 is an FDA 510(k) clearance for the Remington Medical Inc. Tuohy Epidural Needles, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 4, 2015, 120 days after receiving the submission on February 4, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K150266 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2015
Decision Date June 04, 2015
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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