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
May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
MQR
Stent, Colonic, Metallic, Expandable
102d
Cleared
May 12, 2000
URETHROTOME 8667.XXX AND 8670.XXX
EZO
Urethrotome
52d
Cleared
May 09, 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
88d
Cleared
Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Apr 04, 2000
RENAFLO II HF 2000 HEMOFILTER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
90d
Cleared
Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
OCW
Endoscopic Tissue Approximation Device
27d
Cleared
Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
171d
Cleared
Mar 20, 2000
BARD ENDOSCOPIC SUTURING SYSTEM
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
90d
Cleared
Mar 17, 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Mar 16, 2000
MEMOTHERM COLORECTAL STENT
MQR
Stent, Colonic, Metallic, Expandable
393d
Cleared
Mar 15, 2000
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
KGE
Forceps, Biopsy, Electric
63d
Cleared
Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
FHN
Ligator, Hemorrhoidal
29d
Cleared
Mar 03, 2000
KSEA SCB-RUI
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
71d
Cleared
Feb 18, 2000
FLOCATH
KOD
Catheter, Urological
39d
Cleared
Feb 11, 2000
GASTRO-INTESTINAL SYSTEM EN-410WM
FDA
Enteroscope And Accessories
101d
Cleared
Jan 31, 2000
BARD UROFORCE BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
80d
Cleared
Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
MQS
System, Hemodialysis, Access Recirculation Monitoring
90d
Cleared
Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
FFS
Image, Illumination, Fiberoptic, For Endoscope
48d
Cleared
Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
KNQ
Dilator, Esophageal
76d
Cleared
Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jan 06, 2000
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
OCX
Endoscopic Irrigation/suction System
59d
Cleared
Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
FGE
Stents, Drains And Dilators For The Biliary Ducts
51d
Cleared
Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
94d
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