Cleared Traditional

AVID-NIT NERVE STIMULATION NEEDLES

K014246 · Avid N.I.T., Inc. · Anesthesiology
Jul 2002
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K014246 is an FDA 510(k) clearance for the AVID-NIT NERVE STIMULATION NEEDLES, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Avid N.I.T., Inc. (Oldsmar, US). The FDA issued a Cleared decision on July 16, 2002, 202 days after receiving the submission on December 26, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K014246 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2001
Decision Date July 16, 2002
Days to Decision 202 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.