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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5373 Gastroenterology & Urology devices
Cleared
Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
MSE
Hemodialyzer, Re-use, Low Flux
167d
Cleared
Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
OCW
Endoscopic Tissue Approximation Device
88d
Cleared
Nov 01, 2000
MEDOVATIONS ESOPHAGEAL DILATOR
KNQ
Dilator, Esophageal
90d
Cleared
Oct 31, 2000
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
KNW
Instrument, Biopsy
75d
Cleared
Oct 12, 2000
NIR BILLIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
87d
Cleared
Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
ESW
Prosthesis, Esophageal
87d
Cleared
Oct 05, 2000
RAPID EXCHANGE TAPERTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
27d
Cleared
Sep 14, 2000
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
MPB
Catheter, Hemodialysis, Non-implanted
301d
Cleared
Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
216d
Cleared
Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
125d
Cleared
Aug 25, 2000
FRESENIUS OPTIFLUX 200NR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Aug 18, 2000
FLO ASSISTANT, MODEL 4-250-00
LJH
System, Irrigation, Urological
114d
Cleared
Jul 31, 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
49d
Cleared
Jul 28, 2000
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
38d
Cleared
Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
FFK
Lithotriptor, Electro-hydraulic
9d
Cleared
Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jun 27, 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
70d
Cleared
Jun 23, 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
79d
Cleared
Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
FIB
Protector, Transducer, Dialysis
98d
Cleared
Jun 05, 2000
NEPHROSCOPE, 12 DEGREES
FGA
Kit, Nephroscope
173d
Cleared
Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
28d
Cleared
May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
108d
Cleared
May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
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