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Anesthesiology
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Gastroenterology and Urology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
FCP
Box, Battery, Pocket
1
Product Code
FCQ
Light Source, Incandescent, Diagnostic
2
Product Code
EXQ
Cystometer, Electrical Recording
2
Product Code
EXR
Urinometer, Mechanical
2
Product Code
EXS
Urinometer, Electrical
2
Product Code
EXW
Pill, Radio
2
Product Code
EXY
Uroflowmeter
2
Product Code
EXZ
Equipment, Photographic, For Physiologic Function Monitor
1
Product Code
FAJ
Cystoscope And Accessories, Flexible/Rigid
2
Product Code
FAK
Panendoscope (Gastroduodenoscope)
2
Product Code
FAL
Panendoscope (Urethroscope)
2
Product Code
FAM
Sigmoidoscope And Accessories, Flexible/Rigid
2
Product Code
FAN
Sigmoidoscope, Rigid, Electrical
2
Product Code
FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
2
Product Code
FBI
Rongeur, Cystoscopic
2
Product Code
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
2
Product Code
FBN
Choledochoscope And Accessories, Flexible/Rigid
2
Product Code
FBO
Cystourethroscope
2
Product Code
FBP
Telescope, Rigid, Endoscopic
2
Product Code
FCC
Endoscopic Magnetic Retriever
2
Product Code
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
2
Product Code
FCG
Biopsy Needle
2
Product Code
K
24
1209
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
2
Cleared 510(K)
K
23
1422
Precision GI
2
Cleared 510(K)
K
23
1267
ClearTip
2
Cleared 510(K)
K
23
0909
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
2
Cleared 510(K)
K
21
2423
EndoDrill® Model X
2
Cleared 510(K)
K
21
2819
Disposable Biopsy Refill Needle
2
Cleared 510(K)
K
21
2822
Disposable Coaxial Biopsy Needle
2
Cleared 510(K)
K
21
0476
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
2
Cleared 510(K)
K
19
1472
Biopsy Needle
2
Cleared 510(K)
K
18
1756
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
2
Cleared 510(K)
K
18
0668
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
2
Cleared 510(K)
K
18
0363
Clear-Tip EUS-FNA
2
Cleared 510(K)
K
18
1994
Single Use Aspiration Needle NA-U201H
2
Cleared 510(K)
K
18
0449
Single Use Aspiration Needle NA-U200H
2
Cleared 510(K)
K
18
0037
Beacon EUS Access System
2
Cleared 510(K)
K
17
1956
Sterile Endoscope Biopsy Sampling Needle
2
Cleared 510(K)
K
17
1596
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
2
Cleared 510(K)
K
16
0890
Howell Biliary Introducer Needle
2
Cleared 510(K)
K
16
0423
Perineologic Access Needle
2
Cleared 510(K)
K
16
0098
Single Use Aspiration Needle NA-U401SX
2
Cleared 510(K)
K
16
0229
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
2
Cleared 510(K)
K
15
1738
Single Use Aspiration Needle NA-U200H
2
Cleared 510(K)
K
15
1895
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
2
Cleared 510(K)
K
15
1373
Corvocet Coaxial Introducer
2
Cleared 510(K)
K
15
0891
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
2
Cleared 510(K)
K
14
2688
Echotip Procore HD Ultrasound Biopsy Needle
2
Cleared 510(K)
K
13
1925
HS NOTA
2
Cleared 510(K)
K
14
1894
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
2
Cleared 510(K)
K
13
3763
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
2
Cleared 510(K)
K
14
0137
SAFETY BIOPSY NEEDLE SYSTEM
2
Cleared 510(K)
K
13
3008
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
2
Cleared 510(K)
K
10
3694
TISSUE SAMPLING NEEDLE
2
Cleared 510(K)
K
10
3668
BNX FINE NEEDLE ASPIRATION SYSTEM
2
Cleared 510(K)
K
10
0712
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
2
Cleared 510(K)
K
09
3195
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
2
Cleared 510(K)
K
09
2359
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
2
Cleared 510(K)
K
09
1257
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
2
Cleared 510(K)
K
08
3802
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
2
Cleared 510(K)
K
08
3330
ECHOTIP ULTRA ULTRASOUND NEEDLE
2
Cleared 510(K)
K
08
1323
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
2
Cleared 510(K)
K
07
3399
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
2
Cleared 510(K)
K
06
2979
THYROSAMPLER
2
Cleared 510(K)
K
07
0179
TROKABONE, TROKABONE STERNAL
2
Cleared 510(K)
K
07
0129
SONOTIP II ULTRASOUND NEEDLE SYSTEM
2
Cleared 510(K)
K
05
1506
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
2
Cleared 510(K)
K
05
0135
K-C HEMOSTATIC BIOPSY SYSTEM
2
Cleared 510(K)
K
05
1247
SONOTIP II ULTRASOUND NEEDLE SYSTEM
2
Cleared 510(K)
K
05
0503
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
2
Cleared 510(K)
K
05
0120
EASY CORE BIOPSY SYSTEM II
2
Cleared 510(K)
K
04
0893
EASY CORE BIOPSY SYSTEM
2
Cleared 510(K)
K
02
4120
MODIFICATION TO TEMNO BIOPSY NEEDLES
2
Cleared 510(K)
K
02
3272
DISPOSABLE ASPIRATION NEEDLE NA-200H
2
Cleared 510(K)
K
02
1847
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
2
Cleared 510(K)
K
02
1525
TOPCUT
2
Cleared 510(K)
K
01
3109
SONOPSY
2
Cleared 510(K)
K
01
3069
BIOSPEED
2
Cleared 510(K)
K
01
3071
SECURCUT ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
01
3070
JAMSHIDI BIOPSY NEEDLE
2
Cleared 510(K)
K
01
2864
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
2
Cleared 510(K)
K
01
3356
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
2
Cleared 510(K)
K
01
2358
CHIBA NEEDLE
2
Cleared 510(K)
K
01
1075
EASYBELL
2
Cleared 510(K)
K
01
1270
AUTOMATED CORE BIOPSY DEVICE
2
Cleared 510(K)
K
00
2946
SILENT BIOPSY NEEDLE
2
Cleared 510(K)
K
00
2944
PRECISA BIOPSY NEEDLE
2
Cleared 510(K)
K
00
2947
BIOMOL ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
99
1672
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
2
Cleared 510(K)
K
99
0220
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
2
Cleared 510(K)
K
98
3218
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
2
Cleared 510(K)
K
98
1889
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
2
Cleared 510(K)
K
96
3565
MRI NEEDLES
2
Cleared 510(K)
K
97
1842
COAXIAL NEEDLE
2
Cleared 510(K)
K
97
0563
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
2
Cleared 510(K)
K
96
3894
SMARTGUIDE
2
Cleared 510(K)
K
96
1897
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
96
2569
BIOMID BONE MARROW BIOPSY NEEDLE
2
Cleared 510(K)
K
96
2570
ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
96
2568
ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
2
Cleared 510(K)
K
96
2905
TX BIOPSY NEEDLE
2
Cleared 510(K)
K
96
1185
DAUM BIOPSYNEEDLE
2
Cleared 510(K)
K
96
0317
LAURUS NEEDLE CORE BIOPSY SYSTEM
2
Cleared 510(K)
K
94
3304
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
2
Cleared 510(K)
K
95
1421
GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
2
Cleared 510(K)
K
95
4596
PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM
2
Cleared 510(K)
K
95
4231
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
2
Cleared 510(K)
K
95
4155
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
94
1722
FNA BIOPSY NEEDLE
2
Cleared 510(K)
K
95
1598
PRO-B BIOPSY NEEDLE
2
Cleared 510(K)
K
95
0982
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
2
Cleared 510(K)
K
95
0810
RUTNER BIOPSY DEVICE
2
Cleared 510(K)
K
93
5844
GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
2
Cleared 510(K)
K
94
5813
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
2
Cleared 510(K)
K
94
5921
ECHO STAR NEEDLE SET
2
Cleared 510(K)
K
94
5146
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
94
4944
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
2
Cleared 510(K)
K
94
5133
MODIFIED BIOPSY NEEDLE
2
Cleared 510(K)
K
94
1563
THE BIOPSY TOOL
2
Cleared 510(K)
K
93
4256
GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
2
Cleared 510(K)
K
93
6194
COAXIAL BIOPSY NEEDLE
2
Cleared 510(K)
K
91
5801
BIP-COAX-SYSTEM
2
Cleared 510(K)
K
93
4370
BIP BIOPSY NEEDLE MODIFICATION
2
Cleared 510(K)
K
93
4356
WILSON-COOK GI ASPIRATION NEEDLE
2
Cleared 510(K)
K
92
6559
PROACT BIOPSY NEEDLE ENCHANCEMENTS
2
Cleared 510(K)
K
92
4271
CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
2
Cleared 510(K)
K
91
4732
CORE MEDICAL BIOPSY NEEDLE
2
Cleared 510(K)
K
91
0720
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
2
Cleared 510(K)
K
91
1397
HYPODERMIC NEEDLES, SINGLE LUMEN
2
Cleared 510(K)
K
90
5556
HIGH SPEED CORE CUT BIOPSY GUN
2
Cleared 510(K)
K
90
2320
BAUER FLEXI-TEMNO BIOPSY NEEDLE
2
Cleared 510(K)
K
90
2319
BAUER TEMNO BIOPSY NEEDLE
2
Cleared 510(K)
K
89
6932
INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE
2
Cleared 510(K)
K
89
5725
BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
2
Cleared 510(K)
K
89
5897
MANAN PROSTATIC BIOPSY NEEDLE
2
Cleared 510(K)
K
89
2068
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE
2
Cleared 510(K)
K
89
1777
PRO-CUT BIOPSY NEEDLE
2
Cleared 510(K)
K
89
0327
BIOPSY NEEDLE GUIDE ATTACHMENT
2
Cleared 510(K)
K
89
0203
ADMS BIOPSY NEEDLE
2
Cleared 510(K)
K
88
2549
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
2
Cleared 510(K)
K
87
1467
BIOPSY NEEDLE GUIDE KIT, STERILE
2
Cleared 510(K)
K
85
4404
ROTEX SCREW BIOPSY NEEDLE
2
Cleared 510(K)
K
85
4289
MEDSURG ULTRASOUND BIOPSY TRAY
2
Cleared 510(K)
K
84
4993
COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720
2
Cleared 510(K)
K
84
0144
YAG LASER 8000 GASTROINTESTINAL BLEE
2
Cleared 510(K)
K
84
0354
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
2
Cleared 510(K)
K
84
0168
WESTERMAN-JENSEN BIOPSY NEEDLE
2
Cleared 510(K)
K
84
0157
MILLEREISEN CURVED BIOPSY NEEDLE
2
Cleared 510(K)
K
83
4249
MONOJECT SOFT TISSUE BIOPSY NEEDLE
2
Cleared 510(K)
K
80
0420
ADT PERCUTANEOUS NON-DISP. NEEDLE
2
Cleared 510(K)
K
80
0419
ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL
2
Cleared 510(K)
K
80
0416
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
2
Cleared 510(K)
K
77
1108
NEEDLE, CHIBA UNIVERSITY
2
Cleared 510(K)
FCI
Punch, Biopsy
2
Product Code
FCK
Instrument, Biopsy, Suction
2
Product Code
FCL
Forceps, Biopsy, Non-Electric
1
Product Code
FCO
Box, Battery, Rechargeable
1
Product Code
FCR
Light Source, Photographic, Fiberoptic
2
Product Code
FCW
Light Source, Fiberoptic, Routine
2
Product Code
FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
2
Product Code
FCY
Bulb, Inflation, For Endoscope
1
Product Code
FCZ
Tube, Smoke Removal, Endoscopic
1
Product Code
FDA
Enteroscope And Accessories
2
Product Code
FDC
Resectoscope, Working Element
2
Product Code
FDE
Laparoscopy Kit
2
Product Code
FDF
Colonoscope And Accessories, Flexible/Rigid
2
Product Code
FDR
Sphyncteroscope
2
Product Code
FDS
Gastroscope And Accessories, Flexible/Rigid
2
Product Code
FDT
Duodenoscope And Accessories, Flexible/Rigid
2
Product Code
FDW
Esophagoscope, Rigid, Gastro-Urology
2
Product Code
FDX
Endoscopic Cytology Brush
2
Product Code
FDY
Device, Measuring, For Panendoscope
1
Product Code
FDZ
Attachment, Eyepiece, For Insertion Of Prescription Lens
1
Product Code
FEA
Attachment, Teaching, For Endoscope
1
Product Code
FEC
Obturator, For Endoscope
2
Product Code
FED
Endoscopic Access Overtube, Gastroenterology-Urology
2
Product Code
FEI
Instrument, Special Lens, For Endoscope
1
Product Code
FEJ
Attachment, Binocular, For Endoscope
1
Product Code
FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
1
Product Code
FEN
Device, Cystometric, Hydraulic
2
Product Code
FEQ
Pump, Air, Non-Manual, For Endoscope
2
Product Code
FER
Anoscope And Accessories
2
Product Code
FES
Recorder, External, Pressure, Amplifier & Transducer
2
Product Code
FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
2
Product Code
FFF
Cover, Biopsy Forceps
1
Product Code
FFG
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
2
Product Code
FFS
Image, Illumination, Fiberoptic, For Endoscope
2
Product Code
FFT
Electrode, Ph, Stomach
1
Product Code
FFX
System, Gastrointestinal Motility (Electrical)
2
Product Code
FFY
Adaptor, Bulbs, Miscellaneous, For Endoscope
1
Product Code
FFZ
Cord, Electric, For Endoscope
2
Product Code
FGA
Kit, Nephroscope
2
Product Code
FGB
Ureteroscope And Accessories, Flexible/Rigid
2
Product Code
FGC
Urethroscope
2
Product Code
FGS
Carrier, Sponge, Endoscopic
2
Product Code
FHO
Pneumoperitoneum Needle
2
Product Code
FHP
Needle, Pneumoperitoneum, Simple
2
Product Code
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
2
Product Code
FJL
Resectoscope
2
Product Code
FTI
Lamp, Endoscope, Incandescent
2
Product Code
FTJ
Colonoscope, General & Plastic Surgery
2
Product Code
GCF
Proctoscope
2
Product Code
GCK
Gastroscope, General & Plastic Surgery
2
Product Code
GCL
Esophagoscope, General & Plastic Surgery
2
Product Code
GCM
Endoscope, Rigid
2
Product Code
GCN
Endoscope, Prism
2
Product Code
GCO
Endoscope, Mirror
2
Product Code
GCP
Endoscope, Ac-Powered And Accessories
2
Product Code
GCQ
Endoscope, Flexible
2
Product Code
GCS
Endoscope, Battery-Powered And Accessories
2
Product Code
GCT
Light Source, Endoscope, Xenon Arc
2
Product Code
GCW
Transformer, Endoscope
2
Product Code
GDB
Endoscope, Fiber Optic
2
Product Code
KDM
Sigmoidoscope, Rigid, Non-Electrical
2
Product Code
KDO
Rongeur, Cystoscopic, Hot
2
Product Code
KGD
Scissors For Cystoscope
2
Product Code
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
2
Product Code
KNW
Instrument, Biopsy
2
Product Code
MNK
Endoscopic Bite Block
1
Product Code
MNL
Accessories, Cleaning Brushes, For Endoscope
1
Product Code
MYE
System, Electrogastrography (Egg)
2
Product Code
NBG
Marker, Colon
2
Product Code
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
2
Product Code
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
2
Product Code
NLS
Instrument, Biopsy, Reprocessed
2
Product Code
NLX
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
2
Product Code
NMX
Needle And Needle Set, Gastro-Urology, Reprocessed
2
Product Code
NMY
Needle, Endoscopic, Reprocessed
2
Product Code
NON
Forceps, Biopsy, Non-Electric, Reprocessed
1
Product Code
NSI
System, Imaging, Esophageal, Wireless, Capsule
2
Product Code
NTN
Led Light Source
2
Product Code
NWB
Endoscope, Accessories, Narrow Band Spectrum
2
Product Code
NYV
Gastrointestinal Motility System, Capsule
2
Product Code
NWS
Kit, Choledochoscope, Flexible And Rigid
2
Product Code
NWT
Endoscopic Cholangiogram Kit
2
Product Code
NWU
Endoscope Introducer Kit
2
Product Code
OCS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
2
Product Code
OCT
Anti Fog Solution And Accessories, Endoscopy
2
Product Code
OCU
Endoscopic Storage Cover
2
Product Code
OCV
Endoscope Holder
2
Product Code
OCW
Endoscopic Tissue Approximation Device
2
Product Code
OCX
Endoscopic Irrigation/Suction System
2
Product Code
OCY
Endoscopic Guidewire, Gastroenterology-Urology
2
Product Code
OCZ
Endoscopic Grasping/Cutting Instrument, Non-Powered
2
Product Code
ODA
Endoscopic Central Control Unit
2
Product Code
ODB
Endoscopic Contamination Prevention Sheath
2
Product Code
ODC
Endoscope Channel Accessory
2
Product Code
ODD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
2
Product Code
ODE
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
2
Product Code
ODF
Mini Endoscope, Gastroenterology-Urology
2
Product Code
ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
2
Product Code
PCV
Endoscopic Leak Tester
2
Product Code
PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
2
Product Code
PGD
Colon Capsule Imaging System
2
Product Code
PGU
Spatial Imaging For Display Of Endoscope Position
2
Product Code
PHT
Basin For Endoscope Reprocessing
1
Product Code
PLL
Submucosal Injection Agent
2
Product Code
POZ
Biopsy Needle Kit
2
Product Code
PPE
Nephroscope Set
2
Product Code
PRV
Gastro-Urology Biopsy Kit
2
Product Code
PTQ
Endoscopic Magnetic Retriever, Exempt
2
Product Code
QFZ
Gastroenterology-Urology Accessories To A Biopsy Instrument
1
Product Code
PTR
Scissors For Cytoscope, Exempt
2
Product Code
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
2
Product Code
QIJ
Endoscopic Transhepatic Venous Access Needle
2
Product Code
QIS
Esophageal, Mucosal, Electrical Characterization
2
Product Code
QKZ
Magnetically Maneuvered Capsule Endoscopy System
2
Product Code
QNP
Gastrointesinal Lesion Software Detection System
2
Product Code
SBX
Software For Endoscopy Procedure Metrics
2
Product Code
Subpart B—Obstetrical and Gynecological 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—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical 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
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
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
GU
/
subpart-b—diagnostic-devices
/
FCG
/
K911397
View Source
HYPODERMIC NEEDLES, SINGLE LUMEN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K911397
510(k) Type
Traditional
Applicant
POPPER & SONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/20/1991
Days to Decision
52 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
FCP
Box, Battery, Pocket
FCQ
Light Source, Incandescent, Diagnostic
EXQ
Cystometer, Electrical Recording
EXR
Urinometer, Mechanical
EXS
Urinometer, Electrical
EXW
Pill, Radio
EXY
Uroflowmeter
EXZ
Equipment, Photographic, For Physiologic Function Monitor
FAJ
Cystoscope And Accessories, Flexible/Rigid
FAK
Panendoscope (Gastroduodenoscope)
FAL
Panendoscope (Urethroscope)
FAM
Sigmoidoscope And Accessories, Flexible/Rigid
FAN
Sigmoidoscope, Rigid, Electrical
FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FBI
Rongeur, Cystoscopic
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
FBN
Choledochoscope And Accessories, Flexible/Rigid
FBO
Cystourethroscope
FBP
Telescope, Rigid, Endoscopic
FCC
Endoscopic Magnetic Retriever
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
FCG
Biopsy Needle
K
24
1209
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K
23
1422
Precision GI
K
23
1267
ClearTip
K
23
0909
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K
21
2423
EndoDrill® Model X
K
21
2819
Disposable Biopsy Refill Needle
K
21
2822
Disposable Coaxial Biopsy Needle
K
21
0476
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
K
19
1472
Biopsy Needle
K
18
1756
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K
18
0668
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
K
18
0363
Clear-Tip EUS-FNA
K
18
1994
Single Use Aspiration Needle NA-U201H
K
18
0449
Single Use Aspiration Needle NA-U200H
K
18
0037
Beacon EUS Access System
K
17
1956
Sterile Endoscope Biopsy Sampling Needle
K
17
1596
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
K
16
0890
Howell Biliary Introducer Needle
K
16
0423
Perineologic Access Needle
K
16
0098
Single Use Aspiration Needle NA-U401SX
K
16
0229
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
K
15
1738
Single Use Aspiration Needle NA-U200H
K
15
1895
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K
15
1373
Corvocet Coaxial Introducer
K
15
0891
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
K
14
2688
Echotip Procore HD Ultrasound Biopsy Needle
K
13
1925
HS NOTA
K
14
1894
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K
13
3763
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K
14
0137
SAFETY BIOPSY NEEDLE SYSTEM
K
13
3008
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
K
10
3694
TISSUE SAMPLING NEEDLE
K
10
3668
BNX FINE NEEDLE ASPIRATION SYSTEM
K
10
0712
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K
09
3195
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
K
09
2359
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K
09
1257
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K
08
3802
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
K
08
3330
ECHOTIP ULTRA ULTRASOUND NEEDLE
K
08
1323
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
K
07
3399
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
K
06
2979
THYROSAMPLER
K
07
0179
TROKABONE, TROKABONE STERNAL
K
07
0129
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K
05
1506
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
K
05
0135
K-C HEMOSTATIC BIOPSY SYSTEM
K
05
1247
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K
05
0503
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
K
05
0120
EASY CORE BIOPSY SYSTEM II
K
04
0893
EASY CORE BIOPSY SYSTEM
K
02
4120
MODIFICATION TO TEMNO BIOPSY NEEDLES
K
02
3272
DISPOSABLE ASPIRATION NEEDLE NA-200H
K
02
1847
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
K
02
1525
TOPCUT
K
01
3109
SONOPSY
K
01
3069
BIOSPEED
K
01
3071
SECURCUT ASPIRATION BIOPSY NEEDLE
K
01
3070
JAMSHIDI BIOPSY NEEDLE
K
01
2864
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K
01
3356
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K
01
2358
CHIBA NEEDLE
K
01
1075
EASYBELL
K
01
1270
AUTOMATED CORE BIOPSY DEVICE
K
00
2946
SILENT BIOPSY NEEDLE
K
00
2944
PRECISA BIOPSY NEEDLE
K
00
2947
BIOMOL ASPIRATION BIOPSY NEEDLE
K
99
1672
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K
99
0220
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
K
98
3218
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
K
98
1889
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
K
96
3565
MRI NEEDLES
K
97
1842
COAXIAL NEEDLE
K
97
0563
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K
96
3894
SMARTGUIDE
K
96
1897
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
K
96
2569
BIOMID BONE MARROW BIOPSY NEEDLE
K
96
2570
ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
K
96
2568
ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
K
96
2905
TX BIOPSY NEEDLE
K
96
1185
DAUM BIOPSYNEEDLE
K
96
0317
LAURUS NEEDLE CORE BIOPSY SYSTEM
K
94
3304
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K
95
1421
GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
K
95
4596
PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM
K
95
4231
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
K
95
4155
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
K
94
1722
FNA BIOPSY NEEDLE
K
95
1598
PRO-B BIOPSY NEEDLE
K
95
0982
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K
95
0810
RUTNER BIOPSY DEVICE
K
93
5844
GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
K
94
5813
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K
94
5921
ECHO STAR NEEDLE SET
K
94
5146
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K
94
4944
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K
94
5133
MODIFIED BIOPSY NEEDLE
K
94
1563
THE BIOPSY TOOL
K
93
4256
GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
K
93
6194
COAXIAL BIOPSY NEEDLE
K
91
5801
BIP-COAX-SYSTEM
K
93
4370
BIP BIOPSY NEEDLE MODIFICATION
K
93
4356
WILSON-COOK GI ASPIRATION NEEDLE
K
92
6559
PROACT BIOPSY NEEDLE ENCHANCEMENTS
K
92
4271
CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
K
91
4732
CORE MEDICAL BIOPSY NEEDLE
K
91
0720
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K
91
1397
HYPODERMIC NEEDLES, SINGLE LUMEN
K
90
5556
HIGH SPEED CORE CUT BIOPSY GUN
K
90
2320
BAUER FLEXI-TEMNO BIOPSY NEEDLE
K
90
2319
BAUER TEMNO BIOPSY NEEDLE
K
89
6932
INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE
K
89
5725
BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
K
89
5897
MANAN PROSTATIC BIOPSY NEEDLE
K
89
2068
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE
K
89
1777
PRO-CUT BIOPSY NEEDLE
K
89
0327
BIOPSY NEEDLE GUIDE ATTACHMENT
K
89
0203
ADMS BIOPSY NEEDLE
K
88
2549
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K
87
1467
BIOPSY NEEDLE GUIDE KIT, STERILE
K
85
4404
ROTEX SCREW BIOPSY NEEDLE
K
85
4289
MEDSURG ULTRASOUND BIOPSY TRAY
K
84
4993
COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720
K
84
0144
YAG LASER 8000 GASTROINTESTINAL BLEE
K
84
0354
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
K
84
0168
WESTERMAN-JENSEN BIOPSY NEEDLE
K
84
0157
MILLEREISEN CURVED BIOPSY NEEDLE
K
83
4249
MONOJECT SOFT TISSUE BIOPSY NEEDLE
K
80
0420
ADT PERCUTANEOUS NON-DISP. NEEDLE
K
80
0419
ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL
K
80
0416
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
K
77
1108
NEEDLE, CHIBA UNIVERSITY
FCI
Punch, Biopsy
FCK
Instrument, Biopsy, Suction
FCL
Forceps, Biopsy, Non-Electric
FCO
Box, Battery, Rechargeable
FCR
Light Source, Photographic, Fiberoptic
FCW
Light Source, Fiberoptic, Routine
FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
FCY
Bulb, Inflation, For Endoscope
FCZ
Tube, Smoke Removal, Endoscopic
FDA
Enteroscope And Accessories
FDC
Resectoscope, Working Element
FDE
Laparoscopy Kit
FDF
Colonoscope And Accessories, Flexible/Rigid
FDR
Sphyncteroscope
FDS
Gastroscope And Accessories, Flexible/Rigid
FDT
Duodenoscope And Accessories, Flexible/Rigid
FDW
Esophagoscope, Rigid, Gastro-Urology
FDX
Endoscopic Cytology Brush
FDY
Device, Measuring, For Panendoscope
FDZ
Attachment, Eyepiece, For Insertion Of Prescription Lens
FEA
Attachment, Teaching, For Endoscope
FEC
Obturator, For Endoscope
FED
Endoscopic Access Overtube, Gastroenterology-Urology
FEI
Instrument, Special Lens, For Endoscope
FEJ
Attachment, Binocular, For Endoscope
FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
FEN
Device, Cystometric, Hydraulic
FEQ
Pump, Air, Non-Manual, For Endoscope
FER
Anoscope And Accessories
FES
Recorder, External, Pressure, Amplifier & Transducer
FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FFF
Cover, Biopsy Forceps
FFG
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
FFS
Image, Illumination, Fiberoptic, For Endoscope
FFT
Electrode, Ph, Stomach
FFX
System, Gastrointestinal Motility (Electrical)
FFY
Adaptor, Bulbs, Miscellaneous, For Endoscope
FFZ
Cord, Electric, For Endoscope
FGA
Kit, Nephroscope
FGB
Ureteroscope And Accessories, Flexible/Rigid
FGC
Urethroscope
FGS
Carrier, Sponge, Endoscopic
FHO
Pneumoperitoneum Needle
FHP
Needle, Pneumoperitoneum, Simple
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
FJL
Resectoscope
FTI
Lamp, Endoscope, Incandescent
FTJ
Colonoscope, General & Plastic Surgery
GCF
Proctoscope
GCK
Gastroscope, General & Plastic Surgery
GCL
Esophagoscope, General & Plastic Surgery
GCM
Endoscope, Rigid
GCN
Endoscope, Prism
GCO
Endoscope, Mirror
GCP
Endoscope, Ac-Powered And Accessories
GCQ
Endoscope, Flexible
GCS
Endoscope, Battery-Powered And Accessories
GCT
Light Source, Endoscope, Xenon Arc
GCW
Transformer, Endoscope
GDB
Endoscope, Fiber Optic
KDM
Sigmoidoscope, Rigid, Non-Electrical
KDO
Rongeur, Cystoscopic, Hot
KGD
Scissors For Cystoscope
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
KNW
Instrument, Biopsy
MNK
Endoscopic Bite Block
MNL
Accessories, Cleaning Brushes, For Endoscope
MYE
System, Electrogastrography (Egg)
NBG
Marker, Colon
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
NLS
Instrument, Biopsy, Reprocessed
NLX
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
NMX
Needle And Needle Set, Gastro-Urology, Reprocessed
NMY
Needle, Endoscopic, Reprocessed
NON
Forceps, Biopsy, Non-Electric, Reprocessed
NSI
System, Imaging, Esophageal, Wireless, Capsule
NTN
Led Light Source
NWB
Endoscope, Accessories, Narrow Band Spectrum
NYV
Gastrointestinal Motility System, Capsule
NWS
Kit, Choledochoscope, Flexible And Rigid
NWT
Endoscopic Cholangiogram Kit
NWU
Endoscope Introducer Kit
OCS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
OCT
Anti Fog Solution And Accessories, Endoscopy
OCU
Endoscopic Storage Cover
OCV
Endoscope Holder
OCW
Endoscopic Tissue Approximation Device
OCX
Endoscopic Irrigation/Suction System
OCY
Endoscopic Guidewire, Gastroenterology-Urology
OCZ
Endoscopic Grasping/Cutting Instrument, Non-Powered
ODA
Endoscopic Central Control Unit
ODB
Endoscopic Contamination Prevention Sheath
ODC
Endoscope Channel Accessory
ODD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
ODE
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ODF
Mini Endoscope, Gastroenterology-Urology
ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
PCV
Endoscopic Leak Tester
PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
PGD
Colon Capsule Imaging System
PGU
Spatial Imaging For Display Of Endoscope Position
PHT
Basin For Endoscope Reprocessing
PLL
Submucosal Injection Agent
POZ
Biopsy Needle Kit
PPE
Nephroscope Set
PRV
Gastro-Urology Biopsy Kit
PTQ
Endoscopic Magnetic Retriever, Exempt
QFZ
Gastroenterology-Urology Accessories To A Biopsy Instrument
PTR
Scissors For Cytoscope, Exempt
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
QIJ
Endoscopic Transhepatic Venous Access Needle
QIS
Esophageal, Mucosal, Electrical Characterization
QKZ
Magnetically Maneuvered Capsule Endoscopy System
QNP
Gastrointesinal Lesion Software Detection System
SBX
Software For Endoscopy Procedure Metrics
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-b—diagnostic-devices
/
FCG
/
K911397
View Source
HYPODERMIC NEEDLES, SINGLE LUMEN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K911397
510(k) Type
Traditional
Applicant
POPPER & SONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/20/1991
Days to Decision
52 days