FDA 510(k) Gastroenterology & Urology Devices
FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview
FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.
Common device types:
- GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
- Biliary and pancreatic stents - metal and plastic biliary drainage devices
- Urological devices - ureteral stents, catheters, stone retrieval baskets
- Ablation systems - RFA and cryoablation for GI lesions
- Anorectal devices - manometry systems, hemorrhoid treatment
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8434 Gastroenterology & Urology devices
Cleared
Dec 27, 2000
PELVIC MUSCLE THERAPY
HIR
Perineometer
107d
Cleared
Dec 22, 2000
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
FIP
Subsystem, Water Purification
368d
Cleared
Dec 20, 2000
CRIT-LINE MONITOR III (CLM III)
MQS
System, Hemodialysis, Access Recirculation Monitoring
191d
Cleared
Dec 19, 2000
PRECISA BIOPSY NEEDLE
FCG
Biopsy Needle
89d
Cleared
Dec 19, 2000
SILENT BIOPSY NEEDLE
FCG
Biopsy Needle
89d
Cleared
Dec 19, 2000
BIOMOL ASPIRATION BIOPSY NEEDLE
FCG
Biopsy Needle
89d
Cleared
Dec 19, 2000
ACTIS ADJUSTABLE CONSTRICTION LOOP
LKY
Device, External Penile Rigidity
78d
Cleared
Dec 19, 2000
PLASMAKINETIC ENDOUROLOGY SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
29d
Cleared
Dec 15, 2000
AIW WATER SYSTEM FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
238d
Cleared
Dec 15, 2000
VIVANT BREAST LESION LOCALIZATION DEVICE
KNW
Instrument, Biopsy
39d
Cleared
Dec 11, 2000
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
FIP
Subsystem, Water Purification
319d
Cleared
Dec 11, 2000
MERIT DRAINAGE DEPOT
EXF
Bag, Bile Collecting
69d
Cleared
Dec 10, 2000
SNARE,FLEXIBLE
FDI
Snare, Flexible
81d
Cleared
Dec 08, 2000
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
86d
Cleared
Dec 07, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Dec 05, 2000
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FIB
Protector, Transducer, Dialysis
209d
Cleared
Dec 04, 2000
ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
FDF
Colonoscope And Accessories, Flexible/rigid
90d
Cleared
Dec 04, 2000
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
90d
Cleared
Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
FIB
Protector, Transducer, Dialysis
25d
Cleared
Nov 29, 2000
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
HIR
Perineometer
78d
Cleared
Nov 22, 2000
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
FGO
Dislodger, Stone, Flexible
187d
Cleared
Nov 22, 2000
ENTERIC INJECTION CATHETER WITH IRRIGATION
FBK
Endoscopic Injection Needle, Gastroenterology-urology
77d
Cleared
Nov 22, 2000
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
KOC
Accessories, Blood Circuit, Hemodialysis
72d
Cleared
Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
FGE
Stents, Drains And Dilators For The Biliary Ducts
26d
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