CAZ · Class II · 21 CFR 868.5140

FDA Product Code CAZ: Anesthesia Conduction Kit

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.

Leading manufacturers include Arrow Intl., Inc., Kendall Healthcare Products Co. Div.Of Tyco Health and PAJUNK GmbH Medizintechnologie.

155
Total
155
Cleared
129d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Anesthesia Conduction Kit Devices (Product Code CAZ)

155 devices
1–24 of 155
Cleared Feb 13, 2023
Arrow 0.2 Micron Flat Filter, GVS
K222341
Arrow International, LLC
Anesthesiology · 194d
Cleared May 19, 2022
BD Epilor Syringe
K210983
Becton, Dickinson and Company
Anesthesiology · 413d
Cleared Feb 12, 2021
Plastic LOR Syringe
K201356
Jiangsu Caina Medical Co.,Ltd
Anesthesiology · 267d
Cleared Dec 29, 2020
E-Cath STIM acc. Tsui
K202699
PAJUNK GmbH Medizintechnologie
Anesthesiology · 104d
Cleared May 16, 2019
VPC
K190345
PAJUNK GmbH Medizintechnologie
Anesthesiology · 91d
Cleared Oct 04, 2016
Arrow Epidural Catheter Kit
K161075
Teleflexmedical, Inc.
Anesthesiology · 169d
Cleared Jun 21, 2016
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
K153652
Teleflex, Inc.
Anesthesiology · 183d
Cleared Jun 26, 2015
Arrow Epidural Catheter Kit
K143581
Teleflexmedical, Inc.
Anesthesiology · 190d
Cleared Dec 21, 2012
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
K122690
Arrow International, Inc.
Anesthesiology · 108d
Cleared Sep 14, 2012
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K110053
Smiths Medical Asd, Inc.
Anesthesiology · 616d
Cleared Aug 28, 2012
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K122027
Arrow International, Inc.
Anesthesiology · 48d
Cleared Aug 02, 2012
PERIFUSE CATHETER
K121525
Smiths Medical Asd, Inc.
Anesthesiology · 71d
Cleared Jun 20, 2012
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
K121403
Teleflex, Inc.
Anesthesiology · 41d
Cleared May 16, 2012
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
K103658
Teleflex, Inc.
Anesthesiology · 518d
Cleared Apr 20, 2012
FENESTRATED NERVE BLOCK NEEDLE
K113662
Imd, Inc.
Anesthesiology · 135d
Cleared Mar 01, 2012
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113188
PAJUNK GmbH Medizintechnologie
Anesthesiology · 122d
Cleared Jan 24, 2012
CONTIPLEX FX
K113059
B.Braun Medical, Inc.
Anesthesiology · 102d
Cleared Sep 16, 2011
ECHOBRIGHT
K111355
Life-Tech, Inc.
Anesthesiology · 123d
Cleared Nov 04, 2009
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K092657
Smiths Medical Asd, Inc.
Anesthesiology · 68d
Cleared Aug 14, 2009
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K090995
B.Braun Medical, Inc.
Anesthesiology · 129d
Cleared Oct 28, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K082183
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Oct 27, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K082164
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Jun 20, 2007
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282
B.Braun Medical, Inc.
Anesthesiology · 232d
Cleared Jun 07, 2007
PAJUNKS EPILONG SET PEDIATRIC
K062902
PAJUNK GmbH Medizintechnologie
Anesthesiology · 253d

About Product Code CAZ - Regulatory Context

510(k) Submission Activity

155 total 510(k) submissions under product code CAZ since 1976, with 155 receiving FDA clearance (average review time: 129 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.