Cleared Special

MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT

K012584 · Bd · Anesthesiology
Sep 2001
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K012584 is an FDA 510(k) clearance for the MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on September 6, 2001, 27 days after receiving the submission on August 10, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number K012584 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2001
Decision Date September 06, 2001
Days to Decision 27 days
Submission Type Special
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.