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Anesthesiology
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Gastroenterology and Urology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
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
EZT
Pacemaker, Bladder
3
Product Code
EZW
Stimulator, Electrical, Implantable, For Incontinence
3
Product Code
EZY
Device, Incontinence, Mechanical/Hydraulic
3
Product Code
FAH
Dilator, Urethral, Mechanical
2
Product Code
BSS
Tube, Nasogastric
2
Product Code
EXA
Selector, Size, Ostomy
1
Product Code
EXB
Collector, Ostomy
1
Product Code
EXD
Irrigator, Ostomy
2
Product Code
EXE
Protector, Ostomy
1
Product Code
EXF
Bag, Bile Collecting
2
Product Code
EXG
Bag, Urine Collecting, Ureterostomy
1
Product Code
EXH
Bag, Urinary, Ileostomy
1
Product Code
EXI
Device, Paste-On For Incontinence, Sterile
1
Product Code
EXJ
Device, Incontinence, Urosheath Type, Sterile
1
Product Code
EXN
Support, Hernia
1
Product Code
EYA
Stylet, Ureteral
1
Product Code
EYB
Catheter, Ureteral, Gastro-Urology
2
Product Code
EYC
Catheter, Upper Urinary Tract
2
Product Code
EYI
Adaptor, Ureteral Catheter
1
Product Code
EYJ
Holder, Ureteral Catheter
1
Product Code
EYK
Connector, Ureteral Catheter
1
Product Code
EYQ
Garment, Protective, For Incontinence
1
Product Code
EYT
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
1
Product Code
EYZ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
1
Product Code
EZB
Stylet For Catheter, Gastro-Urology
1
Product Code
EZC
Catheter, Coude
2
Product Code
EZD
Catheter, Straight
2
Product Code
EZK
Catheter, Retention Type
2
Product Code
EZL
Catheter, Retention Type, Balloon
2
Product Code
K
24
1424
InnoCare Specialty Foley Catheter
2
Cleared 510(K)
K
23
2469
Rüsch Latex Gold Foley Catheter
2
Cleared 510(K)
K
24
0057
TraumaGuard Intra-abdominal Pressure Sensing System
2
Cleared 510(K)
K
23
3411
Folysil Silicone Catheter
2
Cleared 510(K)
K
23
3013
2-Way 100% Silicone Cleartract Catheter
2
Cleared 510(K)
K
21
2077
Teleflex Rusch SoftSimplastic Foley Catheters
2
Cleared 510(K)
K
23
1101
Flume Catheter
2
Cleared 510(K)
K
22
1020
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
2
Cleared 510(K)
K
22
2118
2-Way 100% Silicone Cleartract Catheter
2
Cleared 510(K)
K
22
1625
2-Way 100% Silicone ClearTract Catheter
2
Cleared 510(K)
K
21
2151
FLUME catheter
2
Cleared 510(K)
K
20
2134
Well Lead All Silicone Foley Catheter with Temperature Sensor
2
Cleared 510(K)
K
20
1776
Foley Balloon Catheter for Urology
2
Cleared 510(K)
K
20
2698
Prefilled Syringe
2
Cleared 510(K)
K
19
2034
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
2
Cleared 510(K)
K
20
0556
AquaFlate Pre-Filled Sterile Water Syringe 10mL
2
Cleared 510(K)
K
18
2463
Silicone Foley Catheter
2
Cleared 510(K)
K
19
0060
Urethrotech UCD
2
Cleared 510(K)
K
18
2635
Signal Catheter
2
Cleared 510(K)
K
18
1616
PSM 3-Way Silicone Foley Catheter
2
Cleared 510(K)
K
18
0781
Bard Vertus Foley Catheter
2
Cleared 510(K)
K
18
1814
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
2
Cleared 510(K)
K
17
3657
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
2
Cleared 510(K)
K
18
1346
CystoSure Plus Catheter
2
Cleared 510(K)
K
17
3340
Yikang Latex Foley Catheter
2
Cleared 510(K)
K
17
2807
Silicone Foley Catheter for single use
2
Cleared 510(K)
K
17
3533
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
2
Cleared 510(K)
K
17
2422
Kohli Urinary Drainage Catheter
2
Cleared 510(K)
K
16
1770
Rusch Silicone Foley Catheter
2
Cleared 510(K)
K
16
2989
Rusch Simplastic Foley Catheters
2
Cleared 510(K)
K
15
3655
Accuryn Monitoring System
2
Cleared 510(K)
K
15
0550
SilverCoat Silicone Foley Catheter
2
Cleared 510(K)
K
15
0699
Bard LubriGuard Foley Catheter
2
Cleared 510(K)
K
14
2635
Medline Silicone Foley Catheter
2
Cleared 510(K)
K
14
0667
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
14
0099
LIGHTHOUSE URINARY CATHETER
2
Cleared 510(K)
K
13
1655
LIGHTHOUSE(TM) URINARY CATHETER
2
Cleared 510(K)
K
13
0908
DISPOSABLE SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
13
1020
TEMPERATURE SENSOR CATHETER
2
Cleared 510(K)
K
11
0214
DIRECTVISION CATHETER, UNCOATED
2
Cleared 510(K)
K
10
3371
COUDE/ OR TIEMANN
2
Cleared 510(K)
K
10
1824
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
2
Cleared 510(K)
K
09
1516
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
2
Cleared 510(K)
K
09
1767
3 WAY SILICONE FOLEY BALLOON CATHETER
2
Cleared 510(K)
K
09
1699
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
2
Cleared 510(K)
K
09
0262
PERCUCATH URINARY CATHETER
2
Cleared 510(K)
K
08
2919
UC-CARE POSITIONING SYSTEM
2
Cleared 510(K)
K
08
2815
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
2
Cleared 510(K)
K
07
0582
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
2
Cleared 510(K)
K
07
0558
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
2
Cleared 510(K)
K
07
1049
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
2
Cleared 510(K)
K
07
1423
MEDLINE LATEX FOLEY CATHETER
2
Cleared 510(K)
K
06
2112
SUNMED FOLEY CATHETERS
2
Cleared 510(K)
K
06
3442
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
2
Cleared 510(K)
K
07
0508
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
2
Cleared 510(K)
K
05
2168
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
2
Cleared 510(K)
K
05
3429
ADVANCED UROLOGICAL CATHETER
2
Cleared 510(K)
K
05
1059
AMSURE 100% SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
04
2110
BEAMCATH
2
Cleared 510(K)
K
04
2709
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
2
Cleared 510(K)
K
04
1983
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
2
Cleared 510(K)
K
04
0504
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
2
Cleared 510(K)
K
03
3830
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
2
Cleared 510(K)
K
03
0120
AMSURE FOLEY CATHETER
2
Cleared 510(K)
K
03
1748
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
2
Cleared 510(K)
K
02
4010
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
03
0813
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
2
Cleared 510(K)
K
02
1939
VITALCARE FOLEY CATHETER
2
Cleared 510(K)
K
02
3090
OPTION-VF URINARY CATHETER, FV14218
2
Cleared 510(K)
K
02
1142
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
2
Cleared 510(K)
K
02
2287
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
2
Cleared 510(K)
K
00
2612
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
2
Cleared 510(K)
K
01
3276
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
2
Cleared 510(K)
K
01
3174
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
2
Cleared 510(K)
K
01
3172
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
2
Cleared 510(K)
K
01
0006
DRAINAGE CATHETER OR FOLEY CATHETER
2
Cleared 510(K)
K
00
3784
MENTOR SELF-CATH PLUS
2
Cleared 510(K)
K
00
3289
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
2
Cleared 510(K)
K
00
2868
BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER
2
Cleared 510(K)
K
99
3063
RUSCH BRILLANT SILICONE FOLEY
2
Cleared 510(K)
K
99
0500
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
2
Cleared 510(K)
K
99
0509
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
2
Cleared 510(K)
K
98
4084
BARDEX LUBRI-SIL FOLEY CATHETER
2
Cleared 510(K)
K
98
2970
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
2
Cleared 510(K)
K
97
3076
EUROMEDICAL HAEMATURIA FOLEY CATHETER
2
Cleared 510(K)
K
98
2626
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
2
Cleared 510(K)
K
98
1612
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
2
Cleared 510(K)
K
98
0870
RUSCH SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
98
0919
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
2
Cleared 510(K)
K
97
4419
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
2
Cleared 510(K)
K
97
2184
RUSCH BRILLANT SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
97
1643
RUSCH BRILLANT BALLOON CATHETER
2
Cleared 510(K)
K
97
1796
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
2
Cleared 510(K)
K
97
1801
LAPAROTOMY BLADDER NECK SUSPENSION KIT
2
Cleared 510(K)
K
96
4757
CONTIDRAIN CATHETER
2
Cleared 510(K)
K
97
0716
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
2
Cleared 510(K)
K
96
4575
SYMPACATH HYDROGEL COATED FOLEY
2
Cleared 510(K)
K
96
1697
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
2
Cleared 510(K)
K
94
4673
MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
2
Cleared 510(K)
K
94
4676
MRI'S ALL SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
95
4752
PEDIATRIC EUROPHYLIC FOLEY CATHETER
2
Cleared 510(K)
K
94
4007
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
2
Cleared 510(K)
K
95
1106
SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
95
1103
SILASTIC BRAND FOLEY CATHETER
2
Cleared 510(K)
K
94
5806
SILICATH ALL SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
94
1692
FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
2
Cleared 510(K)
K
94
4382
ORION ALL SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
94
4376
ORION ALL SILICONE ELASTOMER COATED CATHETER
2
Cleared 510(K)
K
94
4380
ORION FOLEY CATHETER
2
Cleared 510(K)
K
94
4381
ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
2
Cleared 510(K)
K
94
1488
DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
2
Cleared 510(K)
K
93
4895
GLASSMAN SILICONE CATHETER
2
Cleared 510(K)
K
93
5630
NORTA
2
Cleared 510(K)
K
93
0344
SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
93
2809
FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR
2
Cleared 510(K)
K
91
1617
UROTECH CATHETER
2
Cleared 510(K)
K
92
2821
YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
2
Cleared 510(K)
K
92
1561
YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES
2
Cleared 510(K)
K
90
5042
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
2
Cleared 510(K)
K
90
3777
WRP FOLEYCATH
2
Cleared 510(K)
K
90
2710
FOLEY CATHETER
2
Cleared 510(K)
K
89
4883
PHYCON ALL SILICONE BALLOON CATHETER
2
Cleared 510(K)
K
81
0691
CURITY 100% SILICONE IRRIGATION FOLEY
2
Cleared 510(K)
K
78
0062
CATHETER/HEMOSTATIC/GERIATRIC
2
Cleared 510(K)
K
77
2218
CATHETER, SILICONE COATED
2
Cleared 510(K)
K
77
1860
FOLHY CATHETER
2
Cleared 510(K)
EZM
Dilator, Esophageal (Metal Olive) Gastro-Urology
2
Product Code
EZN
Dilator, Catheter, Ureteral
2
Product Code
EZQ
Pouch, Colostomy
1
Product Code
EZR
Cement, Stomal Appliance, Ostomy
1
Product Code
EZS
Appliance, Colostomy, Disposable
1
Product Code
FAQ
Bag, Urine Collection, Leg, For External Use, Sterile
1
Product Code
FAT
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
2
Product Code
FAX
Bougie, Urological
1
Product Code
FBM
Cannula And Trocar, Suprapubic, Non-Disposable
1
Product Code
FBR
Urethrometer
1
Product Code
FBW
Filiform And Filiform Follower
1
Product Code
FBX
Sound, Urethral, Metal Or Plastic
1
Product Code
FCB
Bag, Hemostatic
2
Product Code
FCE
Enema Kit
1
Product Code
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
2
Product Code
FCN
Urinary Drainage Collection Kit, For Indwelling Catheter
2
Product Code
FEF
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
2
Product Code
FEG
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
2
Product Code
FEW
Catheter, Malecot
2
Product Code
FEX
Instrument, Catheter, Punch
1
Product Code
FEZ
Catheter And Tube, Suprapubic
2
Product Code
FFA
Tube, Drainage, Suprapubic
2
Product Code
FFH
Collector, Urine, Pediatric, For Indwelling Catheter
2
Product Code
FFP
Dilator, Rectal
1
Product Code
FFW
String And Tubes, Gastrointestinal, To Locate Internal Bleeding
2
Product Code
FGD
Catheter, Retention, Barium Enema With Bag
2
Product Code
FGE
Stents, Drains And Dilators For The Biliary Ducts
2
Product Code
FGF
Catheter, Ureteral Disposable (X-Ray)
2
Product Code
FGH
Catheter, Double Lumen Female Urethrographic
2
Product Code
FGI
Catheter, Urethrographic, Male
2
Product Code
FHA
Clamp, Penile
1
Product Code
FHS
Dialyzer, Single Coil
2
Product Code
FHT
Set, Gavage, Infant, Sterile
2
Product Code
FIA
Chair, Dialysis, Unpowered, Without Scales
1
Product Code
FIB
Protector, Transducer, Dialysis
2
Product Code
FID
Tubing, Dialysate
2
Product Code
FIE
Needle, Fistula
2
Product Code
FIF
Set, Dialysis, Single Needle With Uni-Directional Pump
2
Product Code
FIG
Clamp, Tubing, Blood, Automatic
2
Product Code
FIH
Pump, Infusion Or Syringe, Extra-Luminal
2
Product Code
FII
System, Dialysate Delivery, Sealed
2
Product Code
FIJ
System, Dialysate Delivery, Recirculating, Single Pass
2
Product Code
FIK
System, Dialysate Delivery, Recirculating
2
Product Code
FIL
System, Dialysate Delivery, Single Pass
2
Product Code
FIN
Tank, Holding, Dialysis
2
Product Code
FIP
Subsystem, Water Purification
2
Product Code
FIQ
Cannula, A-V Shunt
2
Product Code
FIR
Pump, Blood, Extra-Luminal
2
Product Code
FIS
Flowmeter, Dialysate
2
Product Code
FIW
Alarm, Pillow Pressure
2
Product Code
FIZ
Meter, Conductivity, Non-Remote
2
Product Code
FJA
Manometer, Water
2
Product Code
FJB
Detector, Dialysate Level
2
Product Code
FJC
Detector, Blood Level
2
Product Code
FJD
Detector, Leak, Blood
2
Product Code
FJF
Detector, Air Bubble
2
Product Code
FJG
Dialyzer, Parallel Flow
2
Product Code
FJH
Dialyzer, Disposable
2
Product Code
FJI
Dialyzer, Capillary, Hollow Fiber
2
Product Code
FJJ
Dialyzer, Twin Coil
2
Product Code
FJK
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
2
Product Code
FJM
Guard, Shunt
2
Product Code
FJN
Stabilizer, Shunt
2
Product Code
FJO
Plier, Tube
1
Product Code
FJP
Adaptor, Y
2
Product Code
FJQ
Connector, Shunt
1
Product Code
FJR
Forceps, Disconnect
1
Product Code
FJS
Catheter, Peritoneal, Long-Term Indwelling
2
Product Code
FJT
Intracatheter, Dialysis
2
Product Code
FJW
Ring, Joint
1
Product Code
FJX
Ring, Crimp
1
Product Code
FJY
Plier, Crimp
1
Product Code
FJZ
Declotting Tray, Kit (Including Contents)
2
Product Code
FKA
Dilator, Vessel
2
Product Code
FKB
Connector, Blood Tubing, Infusion T
2
Product Code
FKC
Clamp, Cannula
1
Product Code
FKD
Canister, Coil
2
Product Code
FKE
Tie, Dialysis
1
Product Code
FKF
Gun, Tie, Dialysis
1
Product Code
FKG
Tray, Start/Stop (Including Contents), Dialysis
1
Product Code
FKH
Solution-Test Standard-Conductivity, Dialysis
2
Product Code
FKI
Set, Dialyzer Holder
2
Product Code
FKJ
Filter, Blood, Dialysis
2
Product Code
FKL
Insert, Pump, Blood
2
Product Code
FKM
Adaptor, Fistula
2
Product Code
FKN
Adaptor, Shunt
2
Product Code
FKO
Catheter, Peritoneal Dialysis, Single Use
2
Product Code
FKP
System, Dialysate Delivery, Single Patient
2
Product Code
FKQ
System, Dialysate Delivery, Central Multiple Patient
2
Product Code
FKR
Subsystem, Proportioning
2
Product Code
FKT
System, Dialysate Delivery, Sorbent Regenerated
2
Product Code
FKW
Tip, Vessel
2
Product Code
FKX
System, Peritoneal, Automatic Delivery
2
Product Code
FKY
Connector, Tubing, Dialysate
2
Product Code
FLA
Monitor, Temperature, Dialysis
2
Product Code
FLB
Meter, Conductivity, Induction, Remote Type
2
Product Code
FLC
Station, Dialysis Control, Negative Pressure Type
2
Product Code
FLD
Apparatus, Hemoperfusion, Sorbent
2
Product Code
FOC
Bag, Urine Collection, Newborn
2
Product Code
FON
Bag, Drainage, With Adhesive, Ostomy
1
Product Code
FPD
Tube, Feeding
2
Product Code
FRQ
Tube, Levine
2
Product Code
GBL
Catheter, Ureteral, General & Plastic Surgery
2
Product Code
GBM
Catheter, Urethral
2
Product Code
GBT
Catheter, Rectal
2
Product Code
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
2
Product Code
GDS
Bag, Stomal
1
Product Code
KDH
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
2
Product Code
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
2
Product Code
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
2
Product Code
KDK
Container, Transport, Kidney
2
Product Code
KDL
Set, Perfusion, Kidney, Disposable
2
Product Code
KDN
System, Perfusion, Kidney
2
Product Code
KGC
Tube, Gastro-Enterostomy
2
Product Code
KNQ
Dilator, Esophageal
2
Product Code
KNR
Adapter, A-V Shunt Or Fistula
2
Product Code
KNT
Tubes, Gastrointestinal (And Accessories)
2
Product Code
KNX
Collector, Urine, (And Accessories) For Indwelling Catheter
2
Product Code
KNY
Accessories, Catheter, G-U
2
Product Code
KNZ
Accessories, A-V Shunt
2
Product Code
KOB
Catheter, Suprapubic (And Accessories)
2
Product Code
KOC
Accessories, Blood Circuit, Hemodialysis
2
Product Code
KOD
Catheter, Urological
2
Product Code
KOE
Dilator, Urethral
2
Product Code
KPF
System, Dialysate Delivery, Semi-Automatic, Peritoneal
2
Product Code
KPH
Catheter, Rectal For Continent Ileostomy
1
Product Code
KPI
Stimulator, Electrical, Non-Implantable, For Incontinence
2
Product Code
KPL
Colonic Irrigation System
2
Product Code
KPM
Shunt, Peritoneal
2
Product Code
KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
2
Product Code
KPP
Peritoneal Dialysate Filter
2
Product Code
KQQ
Tubing, Dialysate (And Connector)
2
Product Code
KQR
Detector, Air Or Foam
2
Product Code
KXM
System Accessories, Extracorporeal
2
Product Code
LBW
Set, Dialysis, Single Needle (Co-Axial Flow)
2
Product Code
LCG
Intestinal Splinting Tubes
2
Product Code
LFJ
Catheter, Subclavian
2
Product Code
LFK
Catheter, Femoral
2
Product Code
LIF
Dialyzer Reprocessing System
2
Product Code
LJH
System, Irrigation, Urological
2
Product Code
LKY
Device, External Penile Rigidity
2
Product Code
LLB
System, Blood, Extracorporeal And Accessories
2
Product Code
LNS
Lithotriptor, Extracorporeal Shock-Wave, Urological
2
Product Code
LQR
Dislodger, Stone, Biliary
2
Product Code
LRI
Ph Meter For Dialysis Hydrogen Ion Concentration
2
Product Code
MJC
Catheter, Urological (Antimicrobial) And Accessories
2
Product Code
MLW
Warmer, Peritoneal Dialysate
2
Product Code
MNG
External Urethral Occluder, Urinary Incontinence-Control, Female
1
Product Code
MNV
Strip, Dialysate Ph Indicator
2
Product Code
MON
System, Hemodialysis, Remote Accessories
1
Product Code
MPB
Catheter, Hemodialysis, Non-Implanted
2
Product Code
MQS
System, Hemodialysis, Access Recirculation Monitoring
2
Product Code
MSB
System And Accessories, Isolated Heart, Transport And Preservation
2
Product Code
MSD
Catheter, Hemodialysis, Implanted
2
Product Code
MSE
Hemodialyzer, Re-Use, Low Flux
2
Product Code
MSF
Hemodialyzer, Re-Use, High Flux
2
Product Code
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
2
Product Code
MSZ
Strip, Test, Reagent, Residuals For Dialysate
2
Product Code
NAM
Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction
2
Product Code
NDS
Media, Culture, Ex Vivo, Tissue And Cell
2
Product Code
NFK
Kit, Repair, Catheter, Hemodialysis
2
Product Code
NHV
System, Water Purification, General Medical Use
2
Product Code
NIE
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
2
Product Code
NIF
Catheter, Hemodialysis, Triple Lumen, Implanted
2
Product Code
NML
Catheter, Biliary, Reprocessed
2
Product Code
NNE
Needle, Fistula, Reprocessed
2
Product Code
NNG
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
2
Product Code
NNW
Bag, Urine Collection, Leg, For External Use, Non-Sterile
1
Product Code
NNX
Device, Incontinence, Urosheath Type, Non-Sterile
1
Product Code
NNY
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
1
Product Code
NNZ
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
1
Product Code
NOA
Device, Paste-On For Incontinence, Non-Sterile
1
Product Code
NOO
Clamp, Dialysis Arm
1
Product Code
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
2
Product Code
NQJ
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
2
Product Code
NTZ
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
2
Product Code
NUB
Colonic Irrigation System, General Well Being
3
Product Code
NYU
Catheter, Hemodialysis, Implanted, Coated
2
Product Code
NWO
Kit, Catheter, Urinary (Exludes Hiv Testing)
2
Product Code
NWP
Suprapubic Cystostomy Catheter Kit
2
Product Code
NWQ
Kit, Catheter, External, Male (Excludes Hiv Testing)
2
Product Code
NWR
Kit, Catheter, Foley (Excludes Hiv Testing)
2
Product Code
NZU
Collector, Urine, Powered, Non Indwelling Catheter
1
Product Code
ODN
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
2
Product Code
ODX
Autonomous Extracorporeal Blood Leak Detector/Alarm
2
Product Code
OHR
Catheter Care Tray
2
Product Code
ONW
Hemodialysis System For Home Use
2
Product Code
ONY
Oral Removable Retainer For Weight Management
2
Product Code
PBP
Rectal Insert
2
Product Code
PCU
Pancreatic Stent, Covered, Metallic, Removable
2
Product Code
PEH
Hemodialysis Catheter Luer End Cap
2
Product Code
PEV
Dialysis Administration Kit
2
Product Code
PEW
Implantable Transprostatic Tissue Retractor System
2
Product Code
PFH
Venous Window Needle Guide
2
Product Code
PIA
Vibrator For Climax Control Of Premature Ejaculation
2
Product Code
PID
Esophageal Dilator Balloon With Or Without Electrode Sensors
2
Product Code
PIE
Esophageal Dilator With Balloon And Electrode Sensors
2
Product Code
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
2
Product Code
QGC
Suprapubic Catheter Accessories
1
Product Code
PIH
Urethral Insert With Pump For Bladder Drainage
2
Product Code
PIN
Kidney Perfusion Kit
2
Product Code
PIO
Enteral Specific Transition Connectors
2
Product Code
PJH
Dynamic Rectal Control System
2
Product Code
PKI
Fully Subcutaneous Implanted Hemodialysis Catheter
2
Product Code
PLI
Gastrointestional Tube Holder
2
Product Code
PLQ
Enzyme Packed Cartridge
2
Product Code
PNB
Biliary Stent System For Benign Strictures
2
Product Code
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
2
Product Code
PNR
Enteral Syringes With Enteral Specific Connectors
2
Product Code
QFQ
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
2
Product Code
PPA
Bladder Irrigation Kit
2
Product Code
PPB
Foley Catheter Kit (Excludes Hiv Testing)
2
Product Code
PPC
Male External Catheterization Kit (Excludes Hiv Testing)
2
Product Code
PPD
Universal Drainage Tray
2
Product Code
PPF
Urinary Irrigation Kit
2
Product Code
PPG
Urinary Drainage Collection Kit
2
Product Code
PPH
Single Needle With Uni-Directional Pump Kit
2
Product Code
PPI
Hemodialysis Tray (Not A Start/Stop Kit)
2
Product Code
PPJ
Peritoneal Dialysis Administration Kit
2
Product Code
PPK
Peritoneal Dialysis Tubing Kit
2
Product Code
PPL
Single Needle (Co-Axial Flow) Dialysis Kit
2
Product Code
PPO
Multi-Lumen Hemodialysis Catheterization Kit
2
Product Code
PQE
Ostomy Care Kit
1
Product Code
PRM
Enteral Administration Kit (Adult & Pediatric)
2
Product Code
PRO
Anti-Regurgitation Blood Tubing Kit
2
Product Code
PRP
Balloon Gastrostomy Tube Kit
2
Product Code
PRQ
Esophageal Dilator Kit
2
Product Code
PRR
Feeding Tube Kit
2
Product Code
PRS
Gastric Colonic Catheter Irrigation Kit
2
Product Code
PRT
Gastric Irrigation And Aspiration Kit
2
Product Code
PRW
Gastrointestinal Tube Kit
2
Product Code
PRX
Gastrostomy Guide Wire Placement Kit
2
Product Code
PRY
Gastrostomy Jejunostomy Feeding Tube Kit
2
Product Code
PRZ
Gastrostomy Tube Kit
2
Product Code
PSA
Laparoscopic Jejunostomy Kit
2
Product Code
PSB
Nasogastric Feed Tube Kit
2
Product Code
PSC
Nasogastric-Gastrojejunal Kit
2
Product Code
PSD
Laparoscopic Gastrostomy Kit
2
Product Code
PSE
Needle Catheter Jejunostomy Kit
2
Product Code
PSF
Non-Balloon Replacement Gastrostomy System
2
Product Code
PSG
Percutaneous Endoscopic Gastrostomy Kit
2
Product Code
PSH
Percutaneous Replacement Gastrostomy Tube Kit
2
Product Code
PSJ
Rectal Dilator Kit
1
Product Code
PSK
Replacement Gastrostomy Feeding Catheter Tray
2
Product Code
PSX
Chlorine Meter
2
Product Code
PTK
Pediatric Esophageal Atresia Anastomosis Device
3
Product Code
PTT
Biliary Catheter For Irrigation And Contrast Injection, Exempt
2
Product Code
PTU
Catheter, Peritoneal, Long-Term Indwelling, Exempt
2
Product Code
PTV
Catheter, Peritoneal Dialysis, Single Use, Exempt
2
Product Code
PTW
System, Peritoneal, Automatic Delivery, Exempt
2
Product Code
QAJ
Cutaneous Electrode Stimulator For Urinary Incontinence
2
Product Code
QAX
Hemodialyzer With Expanded Solute Removal Profile
2
Product Code
QGD
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
1
Product Code
QGE
Biliary Stent, Drain, And Dilator Accessories
1
Product Code
QIR
Pediatric Hemodialysis System
2
Product Code
QMY
Computerized Behavioral Therapy Device For Treating Symptoms
2
Product Code
QON
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
3
Product Code
QRC
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
2
Product Code
SCT
Foley Catheters And Accessories With Additional Safety Features
2
Product Code
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 30 November 2024 at 11:09 am
GU
/
subpart-f—therapeutic-devices
/
EZL
/
K172422
View Source
Kohli Urinary Drainage Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172422
510(k) Type
Traditional
Applicant
Nellie Medical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2018
Days to Decision
183 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
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
EZT
Pacemaker, Bladder
EZW
Stimulator, Electrical, Implantable, For Incontinence
EZY
Device, Incontinence, Mechanical/Hydraulic
FAH
Dilator, Urethral, Mechanical
BSS
Tube, Nasogastric
EXA
Selector, Size, Ostomy
EXB
Collector, Ostomy
EXD
Irrigator, Ostomy
EXE
Protector, Ostomy
EXF
Bag, Bile Collecting
EXG
Bag, Urine Collecting, Ureterostomy
EXH
Bag, Urinary, Ileostomy
EXI
Device, Paste-On For Incontinence, Sterile
EXJ
Device, Incontinence, Urosheath Type, Sterile
EXN
Support, Hernia
EYA
Stylet, Ureteral
EYB
Catheter, Ureteral, Gastro-Urology
EYC
Catheter, Upper Urinary Tract
EYI
Adaptor, Ureteral Catheter
EYJ
Holder, Ureteral Catheter
EYK
Connector, Ureteral Catheter
EYQ
Garment, Protective, For Incontinence
EYT
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
EYZ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
EZB
Stylet For Catheter, Gastro-Urology
EZC
Catheter, Coude
EZD
Catheter, Straight
EZK
Catheter, Retention Type
EZL
Catheter, Retention Type, Balloon
K
24
1424
InnoCare Specialty Foley Catheter
K
23
2469
Rüsch Latex Gold Foley Catheter
K
24
0057
TraumaGuard Intra-abdominal Pressure Sensing System
K
23
3411
Folysil Silicone Catheter
K
23
3013
2-Way 100% Silicone Cleartract Catheter
K
21
2077
Teleflex Rusch SoftSimplastic Foley Catheters
K
23
1101
Flume Catheter
K
22
1020
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
K
22
2118
2-Way 100% Silicone Cleartract Catheter
K
22
1625
2-Way 100% Silicone ClearTract Catheter
K
21
2151
FLUME catheter
K
20
2134
Well Lead All Silicone Foley Catheter with Temperature Sensor
K
20
1776
Foley Balloon Catheter for Urology
K
20
2698
Prefilled Syringe
K
19
2034
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
K
20
0556
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K
18
2463
Silicone Foley Catheter
K
19
0060
Urethrotech UCD
K
18
2635
Signal Catheter
K
18
1616
PSM 3-Way Silicone Foley Catheter
K
18
0781
Bard Vertus Foley Catheter
K
18
1814
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
K
17
3657
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
K
18
1346
CystoSure Plus Catheter
K
17
3340
Yikang Latex Foley Catheter
K
17
2807
Silicone Foley Catheter for single use
K
17
3533
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K
17
2422
Kohli Urinary Drainage Catheter
K
16
1770
Rusch Silicone Foley Catheter
K
16
2989
Rusch Simplastic Foley Catheters
K
15
3655
Accuryn Monitoring System
K
15
0550
SilverCoat Silicone Foley Catheter
K
15
0699
Bard LubriGuard Foley Catheter
K
14
2635
Medline Silicone Foley Catheter
K
14
0667
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
K
14
0099
LIGHTHOUSE URINARY CATHETER
K
13
1655
LIGHTHOUSE(TM) URINARY CATHETER
K
13
0908
DISPOSABLE SILICONE FOLEY CATHETER
K
13
1020
TEMPERATURE SENSOR CATHETER
K
11
0214
DIRECTVISION CATHETER, UNCOATED
K
10
3371
COUDE/ OR TIEMANN
K
10
1824
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
K
09
1516
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
K
09
1767
3 WAY SILICONE FOLEY BALLOON CATHETER
K
09
1699
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
K
09
0262
PERCUCATH URINARY CATHETER
K
08
2919
UC-CARE POSITIONING SYSTEM
K
08
2815
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
K
07
0582
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
K
07
0558
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K
07
1049
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K
07
1423
MEDLINE LATEX FOLEY CATHETER
K
06
2112
SUNMED FOLEY CATHETERS
K
06
3442
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
K
07
0508
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
K
05
2168
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
K
05
3429
ADVANCED UROLOGICAL CATHETER
K
05
1059
AMSURE 100% SILICONE FOLEY CATHETER
K
04
2110
BEAMCATH
K
04
2709
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K
04
1983
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
K
04
0504
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
K
03
3830
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
K
03
0120
AMSURE FOLEY CATHETER
K
03
1748
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
K
02
4010
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
K
03
0813
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
K
02
1939
VITALCARE FOLEY CATHETER
K
02
3090
OPTION-VF URINARY CATHETER, FV14218
K
02
1142
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
K
02
2287
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K
00
2612
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
K
01
3276
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
K
01
3174
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
K
01
3172
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
K
01
0006
DRAINAGE CATHETER OR FOLEY CATHETER
K
00
3784
MENTOR SELF-CATH PLUS
K
00
3289
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU
K
00
2868
BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER
K
99
3063
RUSCH BRILLANT SILICONE FOLEY
K
99
0500
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
K
99
0509
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
K
98
4084
BARDEX LUBRI-SIL FOLEY CATHETER
K
98
2970
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K
97
3076
EUROMEDICAL HAEMATURIA FOLEY CATHETER
K
98
2626
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
K
98
1612
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
K
98
0870
RUSCH SILICONE FOLEY CATHETER
K
98
0919
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
K
97
4419
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
K
97
2184
RUSCH BRILLANT SILICONE FOLEY CATHETER
K
97
1643
RUSCH BRILLANT BALLOON CATHETER
K
97
1796
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
K
97
1801
LAPAROTOMY BLADDER NECK SUSPENSION KIT
K
96
4757
CONTIDRAIN CATHETER
K
97
0716
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
K
96
4575
SYMPACATH HYDROGEL COATED FOLEY
K
96
1697
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
K
94
4673
MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K
94
4676
MRI'S ALL SILICONE FOLEY CATHETER
K
95
4752
PEDIATRIC EUROPHYLIC FOLEY CATHETER
K
94
4007
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K
95
1106
SILICONE FOLEY CATHETER
K
95
1103
SILASTIC BRAND FOLEY CATHETER
K
94
5806
SILICATH ALL SILICONE FOLEY CATHETER
K
94
1692
FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER
K
94
4382
ORION ALL SILICONE FOLEY CATHETER
K
94
4376
ORION ALL SILICONE ELASTOMER COATED CATHETER
K
94
4380
ORION FOLEY CATHETER
K
94
4381
ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K
94
1488
DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
K
93
4895
GLASSMAN SILICONE CATHETER
K
93
5630
NORTA
K
93
0344
SILICONE FOLEY CATHETER
K
93
2809
FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR
K
91
1617
UROTECH CATHETER
K
92
2821
YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
K
92
1561
YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES
K
90
5042
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
K
90
3777
WRP FOLEYCATH
K
90
2710
FOLEY CATHETER
K
89
4883
PHYCON ALL SILICONE BALLOON CATHETER
K
81
0691
CURITY 100% SILICONE IRRIGATION FOLEY
K
78
0062
CATHETER/HEMOSTATIC/GERIATRIC
K
77
2218
CATHETER, SILICONE COATED
K
77
1860
FOLHY CATHETER
EZM
Dilator, Esophageal (Metal Olive) Gastro-Urology
EZN
Dilator, Catheter, Ureteral
EZQ
Pouch, Colostomy
EZR
Cement, Stomal Appliance, Ostomy
EZS
Appliance, Colostomy, Disposable
FAQ
Bag, Urine Collection, Leg, For External Use, Sterile
FAT
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
FAX
Bougie, Urological
FBM
Cannula And Trocar, Suprapubic, Non-Disposable
FBR
Urethrometer
FBW
Filiform And Filiform Follower
FBX
Sound, Urethral, Metal Or Plastic
FCB
Bag, Hemostatic
FCE
Enema Kit
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FCN
Urinary Drainage Collection Kit, For Indwelling Catheter
FEF
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
FEG
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
FEW
Catheter, Malecot
FEX
Instrument, Catheter, Punch
FEZ
Catheter And Tube, Suprapubic
FFA
Tube, Drainage, Suprapubic
FFH
Collector, Urine, Pediatric, For Indwelling Catheter
FFP
Dilator, Rectal
FFW
String And Tubes, Gastrointestinal, To Locate Internal Bleeding
FGD
Catheter, Retention, Barium Enema With Bag
FGE
Stents, Drains And Dilators For The Biliary Ducts
FGF
Catheter, Ureteral Disposable (X-Ray)
FGH
Catheter, Double Lumen Female Urethrographic
FGI
Catheter, Urethrographic, Male
FHA
Clamp, Penile
FHS
Dialyzer, Single Coil
FHT
Set, Gavage, Infant, Sterile
FIA
Chair, Dialysis, Unpowered, Without Scales
FIB
Protector, Transducer, Dialysis
FID
Tubing, Dialysate
FIE
Needle, Fistula
FIF
Set, Dialysis, Single Needle With Uni-Directional Pump
FIG
Clamp, Tubing, Blood, Automatic
FIH
Pump, Infusion Or Syringe, Extra-Luminal
FII
System, Dialysate Delivery, Sealed
FIJ
System, Dialysate Delivery, Recirculating, Single Pass
FIK
System, Dialysate Delivery, Recirculating
FIL
System, Dialysate Delivery, Single Pass
FIN
Tank, Holding, Dialysis
FIP
Subsystem, Water Purification
FIQ
Cannula, A-V Shunt
FIR
Pump, Blood, Extra-Luminal
FIS
Flowmeter, Dialysate
FIW
Alarm, Pillow Pressure
FIZ
Meter, Conductivity, Non-Remote
FJA
Manometer, Water
FJB
Detector, Dialysate Level
FJC
Detector, Blood Level
FJD
Detector, Leak, Blood
FJF
Detector, Air Bubble
FJG
Dialyzer, Parallel Flow
FJH
Dialyzer, Disposable
FJI
Dialyzer, Capillary, Hollow Fiber
FJJ
Dialyzer, Twin Coil
FJK
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
FJM
Guard, Shunt
FJN
Stabilizer, Shunt
FJO
Plier, Tube
FJP
Adaptor, Y
FJQ
Connector, Shunt
FJR
Forceps, Disconnect
FJS
Catheter, Peritoneal, Long-Term Indwelling
FJT
Intracatheter, Dialysis
FJW
Ring, Joint
FJX
Ring, Crimp
FJY
Plier, Crimp
FJZ
Declotting Tray, Kit (Including Contents)
FKA
Dilator, Vessel
FKB
Connector, Blood Tubing, Infusion T
FKC
Clamp, Cannula
FKD
Canister, Coil
FKE
Tie, Dialysis
FKF
Gun, Tie, Dialysis
FKG
Tray, Start/Stop (Including Contents), Dialysis
FKH
Solution-Test Standard-Conductivity, Dialysis
FKI
Set, Dialyzer Holder
FKJ
Filter, Blood, Dialysis
FKL
Insert, Pump, Blood
FKM
Adaptor, Fistula
FKN
Adaptor, Shunt
FKO
Catheter, Peritoneal Dialysis, Single Use
FKP
System, Dialysate Delivery, Single Patient
FKQ
System, Dialysate Delivery, Central Multiple Patient
FKR
Subsystem, Proportioning
FKT
System, Dialysate Delivery, Sorbent Regenerated
FKW
Tip, Vessel
FKX
System, Peritoneal, Automatic Delivery
FKY
Connector, Tubing, Dialysate
FLA
Monitor, Temperature, Dialysis
FLB
Meter, Conductivity, Induction, Remote Type
FLC
Station, Dialysis Control, Negative Pressure Type
FLD
Apparatus, Hemoperfusion, Sorbent
FOC
Bag, Urine Collection, Newborn
FON
Bag, Drainage, With Adhesive, Ostomy
FPD
Tube, Feeding
FRQ
Tube, Levine
GBL
Catheter, Ureteral, General & Plastic Surgery
GBM
Catheter, Urethral
GBT
Catheter, Rectal
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
GDS
Bag, Stomal
KDH
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
KDK
Container, Transport, Kidney
KDL
Set, Perfusion, Kidney, Disposable
KDN
System, Perfusion, Kidney
KGC
Tube, Gastro-Enterostomy
KNQ
Dilator, Esophageal
KNR
Adapter, A-V Shunt Or Fistula
KNT
Tubes, Gastrointestinal (And Accessories)
KNX
Collector, Urine, (And Accessories) For Indwelling Catheter
KNY
Accessories, Catheter, G-U
KNZ
Accessories, A-V Shunt
KOB
Catheter, Suprapubic (And Accessories)
KOC
Accessories, Blood Circuit, Hemodialysis
KOD
Catheter, Urological
KOE
Dilator, Urethral
KPF
System, Dialysate Delivery, Semi-Automatic, Peritoneal
KPH
Catheter, Rectal For Continent Ileostomy
KPI
Stimulator, Electrical, Non-Implantable, For Incontinence
KPL
Colonic Irrigation System
KPM
Shunt, Peritoneal
KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
KPP
Peritoneal Dialysate Filter
KQQ
Tubing, Dialysate (And Connector)
KQR
Detector, Air Or Foam
KXM
System Accessories, Extracorporeal
LBW
Set, Dialysis, Single Needle (Co-Axial Flow)
LCG
Intestinal Splinting Tubes
LFJ
Catheter, Subclavian
LFK
Catheter, Femoral
LIF
Dialyzer Reprocessing System
LJH
System, Irrigation, Urological
LKY
Device, External Penile Rigidity
LLB
System, Blood, Extracorporeal And Accessories
LNS
Lithotriptor, Extracorporeal Shock-Wave, Urological
LQR
Dislodger, Stone, Biliary
LRI
Ph Meter For Dialysis Hydrogen Ion Concentration
MJC
Catheter, Urological (Antimicrobial) And Accessories
MLW
Warmer, Peritoneal Dialysate
MNG
External Urethral Occluder, Urinary Incontinence-Control, Female
MNV
Strip, Dialysate Ph Indicator
MON
System, Hemodialysis, Remote Accessories
MPB
Catheter, Hemodialysis, Non-Implanted
MQS
System, Hemodialysis, Access Recirculation Monitoring
MSB
System And Accessories, Isolated Heart, Transport And Preservation
MSD
Catheter, Hemodialysis, Implanted
MSE
Hemodialyzer, Re-Use, Low Flux
MSF
Hemodialyzer, Re-Use, High Flux
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
MSZ
Strip, Test, Reagent, Residuals For Dialysate
NAM
Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction
NDS
Media, Culture, Ex Vivo, Tissue And Cell
NFK
Kit, Repair, Catheter, Hemodialysis
NHV
System, Water Purification, General Medical Use
NIE
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
NIF
Catheter, Hemodialysis, Triple Lumen, Implanted
NML
Catheter, Biliary, Reprocessed
NNE
Needle, Fistula, Reprocessed
NNG
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
NNW
Bag, Urine Collection, Leg, For External Use, Non-Sterile
NNX
Device, Incontinence, Urosheath Type, Non-Sterile
NNY
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
NNZ
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
NOA
Device, Paste-On For Incontinence, Non-Sterile
NOO
Clamp, Dialysis Arm
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
NQJ
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
NTZ
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
NUB
Colonic Irrigation System, General Well Being
NYU
Catheter, Hemodialysis, Implanted, Coated
NWO
Kit, Catheter, Urinary (Exludes Hiv Testing)
NWP
Suprapubic Cystostomy Catheter Kit
NWQ
Kit, Catheter, External, Male (Excludes Hiv Testing)
NWR
Kit, Catheter, Foley (Excludes Hiv Testing)
NZU
Collector, Urine, Powered, Non Indwelling Catheter
ODN
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
ODX
Autonomous Extracorporeal Blood Leak Detector/Alarm
OHR
Catheter Care Tray
ONW
Hemodialysis System For Home Use
ONY
Oral Removable Retainer For Weight Management
PBP
Rectal Insert
PCU
Pancreatic Stent, Covered, Metallic, Removable
PEH
Hemodialysis Catheter Luer End Cap
PEV
Dialysis Administration Kit
PEW
Implantable Transprostatic Tissue Retractor System
PFH
Venous Window Needle Guide
PIA
Vibrator For Climax Control Of Premature Ejaculation
PID
Esophageal Dilator Balloon With Or Without Electrode Sensors
PIE
Esophageal Dilator With Balloon And Electrode Sensors
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
QGC
Suprapubic Catheter Accessories
PIH
Urethral Insert With Pump For Bladder Drainage
PIN
Kidney Perfusion Kit
PIO
Enteral Specific Transition Connectors
PJH
Dynamic Rectal Control System
PKI
Fully Subcutaneous Implanted Hemodialysis Catheter
PLI
Gastrointestional Tube Holder
PLQ
Enzyme Packed Cartridge
PNB
Biliary Stent System For Benign Strictures
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
PNR
Enteral Syringes With Enteral Specific Connectors
QFQ
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
PPA
Bladder Irrigation Kit
PPB
Foley Catheter Kit (Excludes Hiv Testing)
PPC
Male External Catheterization Kit (Excludes Hiv Testing)
PPD
Universal Drainage Tray
PPF
Urinary Irrigation Kit
PPG
Urinary Drainage Collection Kit
PPH
Single Needle With Uni-Directional Pump Kit
PPI
Hemodialysis Tray (Not A Start/Stop Kit)
PPJ
Peritoneal Dialysis Administration Kit
PPK
Peritoneal Dialysis Tubing Kit
PPL
Single Needle (Co-Axial Flow) Dialysis Kit
PPO
Multi-Lumen Hemodialysis Catheterization Kit
PQE
Ostomy Care Kit
PRM
Enteral Administration Kit (Adult & Pediatric)
PRO
Anti-Regurgitation Blood Tubing Kit
PRP
Balloon Gastrostomy Tube Kit
PRQ
Esophageal Dilator Kit
PRR
Feeding Tube Kit
PRS
Gastric Colonic Catheter Irrigation Kit
PRT
Gastric Irrigation And Aspiration Kit
PRW
Gastrointestinal Tube Kit
PRX
Gastrostomy Guide Wire Placement Kit
PRY
Gastrostomy Jejunostomy Feeding Tube Kit
PRZ
Gastrostomy Tube Kit
PSA
Laparoscopic Jejunostomy Kit
PSB
Nasogastric Feed Tube Kit
PSC
Nasogastric-Gastrojejunal Kit
PSD
Laparoscopic Gastrostomy Kit
PSE
Needle Catheter Jejunostomy Kit
PSF
Non-Balloon Replacement Gastrostomy System
PSG
Percutaneous Endoscopic Gastrostomy Kit
PSH
Percutaneous Replacement Gastrostomy Tube Kit
PSJ
Rectal Dilator Kit
PSK
Replacement Gastrostomy Feeding Catheter Tray
PSX
Chlorine Meter
PTK
Pediatric Esophageal Atresia Anastomosis Device
PTT
Biliary Catheter For Irrigation And Contrast Injection, Exempt
PTU
Catheter, Peritoneal, Long-Term Indwelling, Exempt
PTV
Catheter, Peritoneal Dialysis, Single Use, Exempt
PTW
System, Peritoneal, Automatic Delivery, Exempt
QAJ
Cutaneous Electrode Stimulator For Urinary Incontinence
QAX
Hemodialyzer With Expanded Solute Removal Profile
QGD
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
QGE
Biliary Stent, Drain, And Dilator Accessories
QIR
Pediatric Hemodialysis System
QMY
Computerized Behavioral Therapy Device For Treating Symptoms
QON
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
QRC
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
SCT
Foley Catheters And Accessories With Additional Safety Features
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-f—therapeutic-devices
/
EZL
/
K172422
View Source
Kohli Urinary Drainage Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172422
510(k) Type
Traditional
Applicant
Nellie Medical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2018
Days to Decision
183 days
Submission Type
Summary