Cleared Traditional

STINGRAY EPIDURAL CATHETER CONNECTOR

K051171 · Epimed International, Inc. · Anesthesiology
Aug 2005
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K051171 is an FDA 510(k) clearance for the STINGRAY EPIDURAL CATHETER CONNECTOR, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 26, 2005, 112 days after receiving the submission on May 6, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K051171 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2005
Decision Date August 26, 2005
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAZ — Anesthesia Conduction Kit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.