Product Code: CAZ FDA class 2 21 CFR 868.5140

Anesthesia Conduction Kit

Anesthesiology

The Anesthesia Conduction Kit is a preassembled convenience kit containing the components needed to perform conduction (regional) anesthesia procedures, such as nerve blocks or epidural anesthesia. It is classified as FDA Class 2 (moderate risk); however, per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all criteria in that guidance. The product code is CAZ, regulated under 21 CFR 868.5140, within the Anesthesiology medical specialty. This device is eligible for third-party review.

510(k)s
155
FEI Numbers
84
Registration Numbers
84
Unique Applicants
76
Years Active
47

Basic Information

Product Code
CAZ
Device Class
FDA class 2
Regulation Number
868.5140
Medical Specialty
Anesthesiology
Review Panel
AN
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 155 510(k) clearances via K numbers.

K Number Device Name
K222341 Arrow 0.2 Micron Flat Filter, GVS
K210983 BD Epilor Syringe
K201356 Plastic LOR Syringe
K202699 E-Cath STIM acc. Tsui
K190345 VPC
K161075 Arrow Epidural Catheter Kit
K153652 ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
K143581 Arrow Epidural Catheter Kit
K122690 ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
K110053 CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K122027 ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K121525 PERIFUSE CATHETER
K121403 CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
K103658 FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
K113662 FENESTRATED NERVE BLOCK NEEDLE
K113188 SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K113059 CONTIPLEX FX
K111355 ECHOBRIGHT
K102007 PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
K093662 ECHOBRIGHT
K092657 EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K090995 B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K082183 PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K082164 PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K080804 BUSSE PLASTIC LOR SYRINGE
K073187 PERIPHERAL NERVE BLOCK SUPPORT TRAY
K063282 CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K062902 PAJUNKS EPILONG SET PEDIATRIC
K063018 GLASS LOSS OF RESISTANCE SYRINGE
K062900 PAJUNKS STIMULONG TSUI-METHOD SET
K061737 LOSS OF RESISTANCE SYRINGE
K060186 POLYPLEX STIMULATING CATHETER SYSTEM
K060311 EPILONG KIT FOR ANESTHESIOLOGY
K060563 EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
K052954 CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
K053283 UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
K052946 MPS ACACIA NERVE BLOCK NEEDLE
K051171 STINGRAY EPIDURAL CATHETER CONNECTOR
K043130 MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
K041158 ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
K033018 STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K033080 PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K033952 PERIFIX CATHETER CONNECTOR
K031128 B-SMART, MODEL B-01
K032144 PERIFIX CATHETER CONNECTOR
K022752 PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
K030937 STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
K014246 AVID-NIT NERVE STIMULATION NEEDLES
K021567 STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
K013041 PLEXOLONG SETS
K012584 MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
K994059 CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
K001940 MICOR ANESTHESIA CONDUCTION KIT
K001587 19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001129 PROLONG, MODELS PL50, PL100, PL150
K991719 EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
K983125 EPIDURAL CATHETER MODELS 1210/1200
K971233 SOFT TIP EPIDURAL CATHETER KIT
K962696 PERIFIX PEDIATRIC EPIDURAL KIT
K965017 REGIONAL ANESTHESIA TRAYS
K964783 EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
K962880 SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962821 EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
K961075 MEDCARE REGIONAL ANETHESIA KIT
K960619 MORE-L INJECTOR KIT PLUS
K954706 KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K954953 B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K960100 SPINAL SPECIALTIES NERVE BLOCK TRAY
K954835 HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
K951870 MORELL INJECTOR
K953790 BD PERISAFE EPIDURAL ANESTHESIA TRAY
K953766 KENDALL SAFETAP SPINAL ANESTHESIA TRAY
K953467 B-D SPINAL ANESTHESIA TRAY SPINAL
K944029 CONTINUOUS EPIDURAL ANESTHESIA TRAY
K943319 GERTIE MARX EPI-SPINAL TRAY
K945484 PIDURAL STEROID SYSTEM
K950929 SENSI-TOUCH EPIDURAL ANESTHESIA TRAY
K941153 EPI-SPINAL ANESTHESIA TRAY
K945671 CONTINUOUS EPIDURAL ANESTHESIA TRAY
K945497 B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT
K932614 REGIONAL ANAESTHESIA TRAY
K941343 SPINAL ANESTHESIA TRAY
K941493 KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT
K935245 EPIDURAL ANESTHESIA TRAY
K933721 EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM
K934526 MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY
K931670 CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
K933711 E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY
K932249 DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA
K930161 ANAGO SPINAL ANESTHESIA TRAY
K924707 VARIOUS ANESTHETIC KITS OR TRAYS
K925014 E-SP COMBINED EPI SPINAL MINISET
K922162 CURITY PLASTIC LOSS OF RESISTANCE SYRINGE
K920615 ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT
K925902 B-D LOSS OF RESISTANCE SYRINGE
K912445 MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
K912322 MEGA SPINAL ANESTHESIA KIT
K904440 LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
K903761 CURITY SPINAL ANESTHESIA TRAY
K904101 COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
K903887 CURITY NERVE BLOCK TRAY
K902647 CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
K902312 COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
K896799 PARACERVICAL/PUDENDAL TRAYS
K895955 LOPER CELIAC PLEXUS BLOCK CATHETER KIT
K895476 OPTION EPIDURAL CATHETERS
K896392 MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K894725 MEDIZIV EPIDURAL SYSTEMS
K895192 SPINOCAN(R) CONTINUOUS SPINAL TRAY
K892660 HIBERNATION KIT
K893938 CONTINUOUS EPIDURAL ANESTHESIA TRAY
K891281 INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
K890733 MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012
K890732 MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E
K890731 MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 1002
K890730 MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000
K885278 EPIDURAL ANESTHESIA TRAY
K884552 CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K885277 SPINAL ANESTHESIA TRAY
K885238 CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
K883314 PMT 3721-1 EPIDURAL KIT
K882394 MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K881429 YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
K880970 AXILLARY BLOCK NEEDLE
K874674 AIK-100 ANESTHESIA INDUCTION KIT/TRAY
K880181 REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
K874105 BRACHIAL PLEXUS CATHETER - BP-01200
K873943 CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K871066 CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
K860833 EPIDURAL ANESTHESIA TRAY
K854518 EPIDURAL ANESTHESIA TRAY
K851134 REGIONAL ANESTHESIA TRAYS
K851479 VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
K844982 VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
K842095 EPIDURAL TRAYS
K840179 CONTINUOUS EPIDURAL ANESTHES. TRAY
K840287 BRACHIAL PLEXUS ANESTHESIA TRAY
K832778 EPIDURAL SYRINGE
K822691 VYGON EPIDURAL ANAESTHESIA TRAY
K813186 PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
K802290 REGIONAL INTRAVENOUS ANESTHESIA KIT
K801912 ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
K801724 CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K781469 POSITIVE PLACEMENT ANETHESIA KIT
K782069 TRAY, AUXILLARY BLOCK
K781052 CONTINUOUS EPIDURAL ANESTHESIA TRAY
K780120 ANESTHESIA TRAY, CAUDAL
K770571 TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K770461 ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
K770356 ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
K770096 EPIDURAL BLOCK PROCEDURE PACK
K761162 BRACHIAL PLEXUS BLOCK ANESTHESIA KIT
K760352 CIRCUIT, INTENSIVE CARE VENTILATOR
K760343 TRAY, CURITY CONTINUOUS EPIDURAL
K760249 TRAY, STERILE DISPOSABLE ARTHROGRAM

FEI Numbers

This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.