Cleared Traditional

KENDALL BLUNT TUOHY EPIDURAL NEEDLE

K954706 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology
May 1996
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K954706 is an FDA 510(k) clearance for the KENDALL BLUNT TUOHY EPIDURAL NEEDLE, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on May 30, 1996, 231 days after receiving the submission on October 12, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K954706 FDA.gov
FDA Decision Cleared SESD
Date Received October 12, 1995
Decision Date May 30, 1996
Days to Decision 231 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.