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
8436 Gastroenterology & Urology devices
Cleared
May 17, 1999
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
MSE
Hemodialyzer, Re-use, Low Flux
208d
Cleared
May 17, 1999
GALLINI BYCUT NEEDLE
KNW
Instrument, Biopsy
74d
Cleared
May 17, 1999
JACKSON ESOPHAGEAL DILATOR
KNQ
Dilator, Esophageal
59d
Cleared
May 13, 1999
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
KNW
Instrument, Biopsy
84d
Cleared
May 12, 1999
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
FFX
System, Gastrointestinal Motility (electrical)
90d
Cleared
May 07, 1999
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
78d
Cleared
May 05, 1999
CYSTIC DUCT BALLOON DILATING CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
238d
Cleared
May 03, 1999
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
84d
Cleared
Apr 30, 1999
EXTRACORPOREAL BLOOD CIRCUIT
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
298d
Cleared
Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
MQS
System, Hemodialysis, Access Recirculation Monitoring
158d
Cleared
Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
FGE
Stents, Drains And Dilators For The Biliary Ducts
63d
Cleared
Apr 30, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
FGE
Stents, Drains And Dilators For The Biliary Ducts
32d
Cleared
Apr 28, 1999
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
203d
Cleared
Apr 28, 1999
DAUM NEUROGATE TROCAR
KNW
Instrument, Biopsy
50d
Cleared
Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
KNY
Accessories, Catheter, G-u
22d
Cleared
Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
282d
Cleared
Apr 21, 1999
SERIM BLOOD LEAK TEST STRIP
FJD
Detector, Leak, Blood
90d
Cleared
Apr 21, 1999
URETERAL ACCESS SHEATH SET
FED
Endoscopic Access Overtube, Gastroenterology-urology
43d
Cleared
Apr 19, 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
FJI
Dialyzer, Capillary, Hollow Fiber
90d
Cleared
Apr 15, 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
MPB
Catheter, Hemodialysis, Non-implanted
519d
Cleared
Apr 15, 1999
ALTHIN MEDICAL AB ALTRACART II
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
101d
Cleared
Apr 14, 1999
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
301d
Cleared
Apr 13, 1999
WILTEK HOT BIOPSY FORCEPS
KGE
Forceps, Biopsy, Electric
78d
Cleared
Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
21d
Cleared
Apr 02, 1999
STERICHEK TOTAL CHLORINE TEST KIT
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
143d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices