FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
K
24
1953
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
2
Cleared 510(K)
K
24
1954
SonoBlock; SonoBlock II
2
Cleared 510(K)
K
24
0253
Reach Needle
2
Cleared 510(K)
K
21
2982
Medispine - Spinal Needle, Glospine - Spinal Needle
2
Cleared 510(K)
K
21
1085
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
2
Cleared 510(K)
K
21
0978
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
2
Cleared 510(K)
K
20
3668
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
2
Cleared 510(K)
K
21
2328
DiscCath Needle Set
2
Cleared 510(K)
K
19
3131
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
2
Cleared 510(K)
K
19
2914
Stimuplex Onvision System
2
Cleared 510(K)
K
19
1290
Ancora Nerve Block Catheter Set
2
Cleared 510(K)
K
19
0026
Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
2
Cleared 510(K)
K
18
3316
Dr J Spinal and Epidural Needles
2
Cleared 510(K)
K
17
2823
Portex NRFit Epidural Needles
2
Cleared 510(K)
K
17
3155
Pakter Curved Needle Set
2
Cleared 510(K)
K
17
2410
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
2
Cleared 510(K)
K
17
3110
GRAFTSITE
2
Cleared 510(K)
K
17
3321
StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
2
Cleared 510(K)
K
17
0112
IMD's Lumbar Puncture Needle
2
Cleared 510(K)
K
17
1968
EchoGlo Needle
2
Cleared 510(K)
K
17
1518
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
2
Cleared 510(K)
K
16
3292
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
2
Cleared 510(K)
K
17
0435
NerveGuard NRFit, NerveGuard LUER
2
Cleared 510(K)
K
16
3216
Pinpoint GT Needles
2
Cleared 510(K)
K
16
3435
Entellus Medical Reinforced Anesthesia Needle
2
Cleared 510(K)
K
16
0297
Tuohy NRFit
2
Cleared 510(K)
K
16
0295
SPROTTE NRFit, Quincke NRFit
2
Cleared 510(K)
K
16
0296
SPROTTE SPECIAL NRFit
2
Cleared 510(K)
K
16
0294
SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
2
Cleared 510(K)
K
15
1069
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
2
Cleared 510(K)
K
15
1072
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
2
Cleared 510(K)
K
15
0266
Remington Medical Inc. Tuohy Epidural Needles
2
Cleared 510(K)
K
14
2553
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
2
Cleared 510(K)
K
14
1126
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
2
Cleared 510(K)
K
13
3632
PERICAN ULTRA
2
Cleared 510(K)
K
13
1006
ANESTHESIA CONDUCTION NEEDLES
2
Cleared 510(K)
K
12
1812
SONIXGPS
2
Cleared 510(K)
K
12
0475
ANESTHESIA CONDUCTION NEEDLES
2
Cleared 510(K)
K
12
1846
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
2
Cleared 510(K)
K
11
3207
SONO TAP, TUOHY SONO
2
Cleared 510(K)
K
11
2515
PENCAN SPINAL NEEDLE
2
Cleared 510(K)
K
11
1374
SONO-SERIES CORNERSTONE TECHNIQUE
2
Cleared 510(K)
K
11
0194
MEDLINE EPIDURAL AND SPINAL NEEDLES
2
Cleared 510(K)
K
10
1728
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
2
Cleared 510(K)
K
10
0241
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
2
Cleared 510(K)
K
09
3209
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
2
Cleared 510(K)
K
09
1758
BD SPINAL NEEDLE 27G
2
Cleared 510(K)
K
09
1818
LAURIMED SPINAL INJECTION SYSTEM
2
Cleared 510(K)
K
09
0261
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
2
Cleared 510(K)
K
08
3909
SPINAL INJECTION SYSTEM
2
Cleared 510(K)
K
08
2772
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
2
Cleared 510(K)
K
08
1864
PROLONG
2
Cleared 510(K)
K
08
0603
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
2
Cleared 510(K)
K
08
1446
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
2
Cleared 510(K)
K
08
0140
LAURIMED SPINAL INJECTION SYSTEM
2
Cleared 510(K)
K
07
3222
MODIFICATION TO:SPECIALTY NEEDLES
2
Cleared 510(K)
K
07
3516
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
2
Cleared 510(K)
K
07
2005
RK EPIDURAL NEEDLE
2
Cleared 510(K)
K
06
3350
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
2
Cleared 510(K)
K
07
0354
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
2
Cleared 510(K)
K
06
3380
ECHOSTIM FACET TIP
2
Cleared 510(K)
K
06
3071
DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
2
Cleared 510(K)
K
06
1394
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
2
Cleared 510(K)
K
06
1210
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
2
Cleared 510(K)
K
05
3318
RX EPIDURAL NEEDLE
2
Cleared 510(K)
K
05
0499
PROBLOC, HN SERIES AND PROLONG, PL SERIES
2
Cleared 510(K)
K
04
3500
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
2
Cleared 510(K)
K
04
3467
FLEXIBLE SPINAL NEEDLE
2
Cleared 510(K)
K
04
2979
MODIFICATION TO: PLEXALONG SETS
2
Cleared 510(K)
K
04
0965
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
2
Cleared 510(K)
K
04
1843
PENCIL POINT NEEDLE
2
Cleared 510(K)
K
03
2981
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
2
Cleared 510(K)
K
03
0618
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
2
Cleared 510(K)
K
03
0562
TUOHY EPIDURAL NEEDLE
2
Cleared 510(K)
K
02
3218
MODIFICATION TO PLEXOLONG SETS
2
Cleared 510(K)
K
02
0934
DR. JAPAN FACIL POINT SPINAL NEEDLE
2
Cleared 510(K)
K
02
2029
QUINCKE SPINAL NEEDLE
2
Cleared 510(K)
K
01
3892
LUTZ NEEDLE
2
Cleared 510(K)
K
01
3610
PERIFIX SAFETY EPIDURAL NEEDLES
2
Cleared 510(K)
K
01
3231
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
2
Cleared 510(K)
K
01
1122
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
2
Cleared 510(K)
K
01
1209
MANAN SPRITACRE SPINAL NEEDLES
2
Cleared 510(K)
K
00
2405
SPINAL EPIDURAL NEEDLES
2
Cleared 510(K)
K
99
0519
PHOENIX EPIDURAL & SPINAL NEEDLES
2
Cleared 510(K)
K
99
3619
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
2
Cleared 510(K)
K
00
0722
UNIPOLAR NEEDLES
2
Cleared 510(K)
K
00
0495
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
2
Cleared 510(K)
K
98
3620
MANAN SPINAL NEEDLES
2
Cleared 510(K)
K
98
0536
EPIDURAL NEEDLE
2
Cleared 510(K)
K
97
2595
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
2
Cleared 510(K)
K
95
1928
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
2
Cleared 510(K)
K
96
1152
TUOHY EPIDURAL NEEDLES
2
Cleared 510(K)
K
96
1151
SPINAL NEEDLES
2
Cleared 510(K)
K
96
2886
ANESTHESIA CONDUCTION NEEDLE
2
Cleared 510(K)
K
96
1444
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
2
Cleared 510(K)
K
94
0061
POLYMEDIC SPINAL NEEDLE AND INTRODUCER
2
Cleared 510(K)
K
95
2275
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
2
Cleared 510(K)
K
95
1949
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
2
Cleared 510(K)
K
94
2863
EPIDURAL NEEDLE
2
Cleared 510(K)
K
94
5965
ATRAUMATIC PENCIL POINT SPINAL NEEDLE
2
Cleared 510(K)
K
94
6047
HOLGRATH METAL-HUB, EPIDURAL NEEDLE
2
Cleared 510(K)
K
95
0820
SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
2
Cleared 510(K)
K
94
4907
HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
2
Cleared 510(K)
K
94
4905
HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
2
Cleared 510(K)
K
94
4906
HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
2
Cleared 510(K)
K
94
4908
HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE
2
Cleared 510(K)
K
95
1312
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
2
Cleared 510(K)
K
95
1411
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
2
Cleared 510(K)
K
95
1265
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
2
Cleared 510(K)
K
94
3649
GERTIE MARX NEEDLE
2
Cleared 510(K)
K
93
5255
ELDOR NEEDLE
2
Cleared 510(K)
K
93
2569
PENCIL POINT SPINAL NEEDLE AND TRAY
2
Cleared 510(K)
K
93
2400
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
2
Cleared 510(K)
K
93
1644
GERTIE MARX NEEDLE
2
Cleared 510(K)
K
92
1683
PENCIL POINT SPINAL NEEDLE
2
Cleared 510(K)
K
92
5831
MEDIZIV SPINAL NEEDLE SET
2
Cleared 510(K)
K
92
3003
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
2
Cleared 510(K)
K
92
1288
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
2
Cleared 510(K)
K
92
0305
PHARMASEAL CLEAR HUB SPINAL NEEDLE
2
Cleared 510(K)
K
91
1221
ATRAUMATIC SPECIAL SPROTTE NEEDLE
2
Cleared 510(K)
K
91
1202
ATRAUMATIC STANDARD SPROTTE NEEDLE
2
Cleared 510(K)
K
91
1260
ATRAUMATIC STANDARD SPROTTE NEEDLE
2
Cleared 510(K)
K
91
0652
SPINAL TAP NEEDLE
2
Cleared 510(K)
K
90
1810
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
2
Cleared 510(K)
K
90
1811
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
2
Cleared 510(K)
K
91
0791
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
2
Cleared 510(K)
K
90
3224
EPISENSOR
2
Cleared 510(K)
K
89
4878
16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
2
Cleared 510(K)
K
89
4882
INFILTRATION PUMP SYRINGE
2
Cleared 510(K)
K
89
4881
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
2
Cleared 510(K)
K
89
4880
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
2
Cleared 510(K)
K
89
4879
16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
2
Cleared 510(K)
K
89
5453
SPINAL NEEDLE
2
Cleared 510(K)
K
85
3478
PINPOINT NEEDLE
2
Cleared 510(K)
K
85
4816
EPIDURAL ANESTHESIA NEEDLES
2
Cleared 510(K)
K
85
4149
TSK STERIJECT STERILE EPIDURAL NEEDLE
2
Cleared 510(K)
K
85
1478
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
2
Cleared 510(K)
K
85
0111
AIRES TUOHY NEEDLES 17GA. X 4 1/2
2
Cleared 510(K)
K
84
3313
TOP DISPOSABLE SPINAL NEEDLE
2
Cleared 510(K)
K
83
2126
MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
2
Cleared 510(K)
K
83
2233
EPINEED EPIDURAL NEEDLE
2
Cleared 510(K)
K
82
3692
SPINAL NEEDLE
2
Cleared 510(K)
K
82
2630
MONOJECT PLASTIC HUB SPINAL NEEDLE
2
Cleared 510(K)
K
82
0047
SPINOCAN SPINAL NEEDLE
2
Cleared 510(K)
K
81
3179
PERICAN, EPIDURAL CANNULA
2
Cleared 510(K)
K
81
3236
EPICAN EPIDURAL CANNULA, BEVEL ACCORD
2
Cleared 510(K)
K
81
3165
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
2
Cleared 510(K)
K
81
1963
VISITEC NEEDLE RANGE (ANESTHESIOLOGY)
2
Cleared 510(K)
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BSP
/
K011209
View Source
MANAN SPRITACRE SPINAL NEEDLES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011209
510(k) Type
Traditional
Applicant
MANAN MEDICAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/26/2001
Days to Decision
68 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
K
24
1953
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
K
24
1954
SonoBlock; SonoBlock II
K
24
0253
Reach Needle
K
21
2982
Medispine - Spinal Needle, Glospine - Spinal Needle
K
21
1085
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
K
21
0978
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K
20
3668
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
K
21
2328
DiscCath Needle Set
K
19
3131
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
K
19
2914
Stimuplex Onvision System
K
19
1290
Ancora Nerve Block Catheter Set
K
19
0026
Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
K
18
3316
Dr J Spinal and Epidural Needles
K
17
2823
Portex NRFit Epidural Needles
K
17
3155
Pakter Curved Needle Set
K
17
2410
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
K
17
3110
GRAFTSITE
K
17
3321
StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
K
17
0112
IMD's Lumbar Puncture Needle
K
17
1968
EchoGlo Needle
K
17
1518
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
K
16
3292
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
K
17
0435
NerveGuard NRFit, NerveGuard LUER
K
16
3216
Pinpoint GT Needles
K
16
3435
Entellus Medical Reinforced Anesthesia Needle
K
16
0297
Tuohy NRFit
K
16
0295
SPROTTE NRFit, Quincke NRFit
K
16
0296
SPROTTE SPECIAL NRFit
K
16
0294
SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
K
15
1069
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
K
15
1072
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
K
15
0266
Remington Medical Inc. Tuohy Epidural Needles
K
14
2553
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
K
14
1126
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
K
13
3632
PERICAN ULTRA
K
13
1006
ANESTHESIA CONDUCTION NEEDLES
K
12
1812
SONIXGPS
K
12
0475
ANESTHESIA CONDUCTION NEEDLES
K
12
1846
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
K
11
3207
SONO TAP, TUOHY SONO
K
11
2515
PENCAN SPINAL NEEDLE
K
11
1374
SONO-SERIES CORNERSTONE TECHNIQUE
K
11
0194
MEDLINE EPIDURAL AND SPINAL NEEDLES
K
10
1728
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
K
10
0241
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
K
09
3209
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K
09
1758
BD SPINAL NEEDLE 27G
K
09
1818
LAURIMED SPINAL INJECTION SYSTEM
K
09
0261
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K
08
3909
SPINAL INJECTION SYSTEM
K
08
2772
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
K
08
1864
PROLONG
K
08
0603
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
K
08
1446
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K
08
0140
LAURIMED SPINAL INJECTION SYSTEM
K
07
3222
MODIFICATION TO:SPECIALTY NEEDLES
K
07
3516
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
K
07
2005
RK EPIDURAL NEEDLE
K
06
3350
DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K
07
0354
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
K
06
3380
ECHOSTIM FACET TIP
K
06
3071
DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
K
06
1394
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K
06
1210
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
K
05
3318
RX EPIDURAL NEEDLE
K
05
0499
PROBLOC, HN SERIES AND PROLONG, PL SERIES
K
04
3500
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
K
04
3467
FLEXIBLE SPINAL NEEDLE
K
04
2979
MODIFICATION TO: PLEXALONG SETS
K
04
0965
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
K
04
1843
PENCIL POINT NEEDLE
K
03
2981
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
K
03
0618
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K
03
0562
TUOHY EPIDURAL NEEDLE
K
02
3218
MODIFICATION TO PLEXOLONG SETS
K
02
0934
DR. JAPAN FACIL POINT SPINAL NEEDLE
K
02
2029
QUINCKE SPINAL NEEDLE
K
01
3892
LUTZ NEEDLE
K
01
3610
PERIFIX SAFETY EPIDURAL NEEDLES
K
01
3231
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
K
01
1122
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K
01
1209
MANAN SPRITACRE SPINAL NEEDLES
K
00
2405
SPINAL EPIDURAL NEEDLES
K
99
0519
PHOENIX EPIDURAL & SPINAL NEEDLES
K
99
3619
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
K
00
0722
UNIPOLAR NEEDLES
K
00
0495
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K
98
3620
MANAN SPINAL NEEDLES
K
98
0536
EPIDURAL NEEDLE
K
97
2595
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K
95
1928
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
K
96
1152
TUOHY EPIDURAL NEEDLES
K
96
1151
SPINAL NEEDLES
K
96
2886
ANESTHESIA CONDUCTION NEEDLE
K
96
1444
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
K
94
0061
POLYMEDIC SPINAL NEEDLE AND INTRODUCER
K
95
2275
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
K
95
1949
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K
94
2863
EPIDURAL NEEDLE
K
94
5965
ATRAUMATIC PENCIL POINT SPINAL NEEDLE
K
94
6047
HOLGRATH METAL-HUB, EPIDURAL NEEDLE
K
95
0820
SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
K
94
4907
HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
K
94
4905
HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
K
94
4906
HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
K
94
4908
HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE
K
95
1312
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K
95
1411
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K
95
1265
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K
94
3649
GERTIE MARX NEEDLE
K
93
5255
ELDOR NEEDLE
K
93
2569
PENCIL POINT SPINAL NEEDLE AND TRAY
K
93
2400
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K
93
1644
GERTIE MARX NEEDLE
K
92
1683
PENCIL POINT SPINAL NEEDLE
K
92
5831
MEDIZIV SPINAL NEEDLE SET
K
92
3003
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K
92
1288
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K
92
0305
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K
91
1221
ATRAUMATIC SPECIAL SPROTTE NEEDLE
K
91
1202
ATRAUMATIC STANDARD SPROTTE NEEDLE
K
91
1260
ATRAUMATIC STANDARD SPROTTE NEEDLE
K
91
0652
SPINAL TAP NEEDLE
K
90
1810
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
K
90
1811
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
K
91
0791
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K
90
3224
EPISENSOR
K
89
4878
16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
K
89
4882
INFILTRATION PUMP SYRINGE
K
89
4881
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K
89
4880
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
K
89
4879
16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
K
89
5453
SPINAL NEEDLE
K
85
3478
PINPOINT NEEDLE
K
85
4816
EPIDURAL ANESTHESIA NEEDLES
K
85
4149
TSK STERIJECT STERILE EPIDURAL NEEDLE
K
85
1478
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K
85
0111
AIRES TUOHY NEEDLES 17GA. X 4 1/2
K
84
3313
TOP DISPOSABLE SPINAL NEEDLE
K
83
2126
MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
K
83
2233
EPINEED EPIDURAL NEEDLE
K
82
3692
SPINAL NEEDLE
K
82
2630
MONOJECT PLASTIC HUB SPINAL NEEDLE
K
82
0047
SPINOCAN SPINAL NEEDLE
K
81
3179
PERICAN, EPIDURAL CANNULA
K
81
3236
EPICAN EPIDURAL CANNULA, BEVEL ACCORD
K
81
3165
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
K
81
1963
VISITEC NEEDLE RANGE (ANESTHESIOLOGY)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
BSP
/
K011209
View Source
MANAN SPRITACRE SPINAL NEEDLES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011209
510(k) Type
Traditional
Applicant
MANAN MEDICAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/26/2001
Days to Decision
68 days
Submission Type
Statement