Cleared Traditional

SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)

K133316 · Epimed International, Inc. · Anesthesiology
May 2014
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K133316 is an FDA 510(k) clearance for the SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS), a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on May 28, 2014, 212 days after receiving the submission on October 28, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K133316 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2013
Decision Date May 28, 2014
Days to Decision 212 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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