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Innolitics
Anesthesiology
Review Panel
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Review Panel
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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
K
97
0465
BOUSER'S URINAL
1
Cleared 510(K)
K
97
2100
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
1
Cleared 510(K)
K
97
0966
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
96
3265
PROSYS SAMEC LA
1
Cleared 510(K)
K
96
2900
SELF RETAINING MALE EXTERNAL URINARY CATHETER
1
Cleared 510(K)
K
96
2413
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
96
2384
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
95
2082
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
94
5628
CLEAR ADVANTAGE II
1
Cleared 510(K)
K
95
1530
PROSYS URIHESIVE SYSTEM LA
1
Cleared 510(K)
K
95
0690
PROSYS URIHESICE SYSTEM NL
1
Cleared 510(K)
K
94
2941
CONQUEST MALE CONTINENCE SYSTEM
1
Cleared 510(K)
K
94
6243
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
94
0269
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
1
Cleared 510(K)
K
93
4266
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
93
1156
CONE CATH
1
Cleared 510(K)
K
92
3136
MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
92
4407
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
1
Cleared 510(K)
K
91
3524
SILICONE MALE EXTERNAL CATHETER
1
Cleared 510(K)
K
90
3715
CONDOM SEAL
1
Cleared 510(K)
K
85
1682
SAFESEAL REUSABLE URINAL SYSTEM
1
Cleared 510(K)
K
77
2144
CATHETER, DISP., EXTERNAL, MALE
1
Cleared 510(K)
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
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
/
EXJ
/
K934266
View Source
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934266
510(k) Type
Traditional
Applicant
SIERRA LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/19/1994
Days to Decision
231 days
Submission Type
Statement
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
K
97
0465
BOUSER'S URINAL
K
97
2100
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
K
97
0966
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
K
96
3265
PROSYS SAMEC LA
K
96
2900
SELF RETAINING MALE EXTERNAL URINARY CATHETER
K
96
2413
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
K
96
2384
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
K
95
2082
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
K
94
5628
CLEAR ADVANTAGE II
K
95
1530
PROSYS URIHESIVE SYSTEM LA
K
95
0690
PROSYS URIHESICE SYSTEM NL
K
94
2941
CONQUEST MALE CONTINENCE SYSTEM
K
94
6243
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
K
94
0269
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K
93
4266
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
K
93
1156
CONE CATH
K
92
3136
MALE EXTERNAL CATHETER
K
92
4407
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K
91
3524
SILICONE MALE EXTERNAL CATHETER
K
90
3715
CONDOM SEAL
K
85
1682
SAFESEAL REUSABLE URINAL SYSTEM
K
77
2144
CATHETER, DISP., EXTERNAL, MALE
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
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
/
EXJ
/
K934266
View Source
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934266
510(k) Type
Traditional
Applicant
SIERRA LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/19/1994
Days to Decision
231 days
Submission Type
Statement