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
8435 Gastroenterology & Urology devices
Cleared
Jul 11, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
90d
Cleared
Jul 11, 2000
INSIDE VIEW
GCM
Endoscope, Rigid
85d
Cleared
Jul 10, 2000
SENSATION -VACUUM ASSIST DEVICES
LKY
Device, External Penile Rigidity
174d
Cleared
Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
88d
Cleared
Jul 07, 2000
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
88d
Cleared
Jun 30, 2000
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
88d
Cleared
Jun 30, 2000
GENYX FLEXIBLE INJECTION NEEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
81d
Cleared
Jun 30, 2000
RECTOSIGHT RS 300-04
FER
Anoscope And Accessories
206d
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 08, 2000
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
90d
Cleared
Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
FIB
Protector, Transducer, Dialysis
98d
Cleared
Jun 05, 2000
MEDTRONIC AVE BRIDGE X3 STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jun 05, 2000
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
KNY
Accessories, Catheter, G-u
88d
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 25, 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
192d
Cleared
May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
108d
Cleared
May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
KOD
Catheter, Urological
74d
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
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 12, 2000
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
FEQ
Pump, Air, Non-manual, For Endoscope
50d
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
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