Cleared Traditional

ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT

K920615 · Anago, Inc. · Anesthesiology

Mar 1993

Decision

403d

Days

Class 2

Risk

About This 510(k) Submission

K920615 is an FDA 510(k) clearance for the ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 20, 1993, 403 days after receiving the submission on February 11, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K920615 FDA.gov
FDA Decision	Cleared SEKD
Date Received	February 11, 1992
Decision Date	March 20, 1993
Days to Decision	403 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

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.