Cleared Traditional

FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837

K051860 · Epimed International, Inc. · Anesthesiology
Aug 2005
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K051860 is an FDA 510(k) clearance for the FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837, a Needle, Spinal, Short Term (Class II — Special Controls, product code MIA), submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 22, 2005, 45 days after receiving the submission on July 8, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K051860 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2005
Decision Date August 22, 2005
Days to Decision 45 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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