Cleared Traditional

K965017 - REGIONAL ANESTHESIA TRAYS
(FDA 510(k) Clearance)

K965017 · Smiths Industries Medical Systems, Inc. · Anesthesiology

Mar 1997

Decision

88d

Days

Class 2

Risk

K965017 is an FDA 510(k) clearance for the REGIONAL ANESTHESIA TRAYS, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on March 14, 1997, 88 days after receiving the submission on December 16, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K965017 FDA.gov
FDA Decision	Cleared SEKD
Date Received	December 16, 1996
Decision Date	March 14, 1997
Days to Decision	88 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.