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
8431 Gastroenterology & Urology devices
Cleared
Jun 22, 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
FIP
Subsystem, Water Purification
189d
Cleared
Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
79d
Cleared
Jun 22, 2001
TAUT BALLOON CATHETER, MODEL 50640
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
79d
Cleared
Jun 22, 2001
AUTOMATED CORE BIOPSY DEVICE
FCG
Biopsy Needle
57d
Cleared
Jun 22, 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
43d
Cleared
Jun 22, 2001
DORNIER LITHOTRIPTER 140(DOLI 140)
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
15d
Cleared
Jun 21, 2001
MEDCOMP ASH SPLIT
NFK
Kit, Repair, Catheter, Hemodialysis
30d
Cleared
Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
FJI
Dialyzer, Capillary, Hollow Fiber
58d
Cleared
Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
MSD
Catheter, Hemodialysis, Implanted
242d
Cleared
Jun 11, 2001
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
90d
Cleared
Jun 08, 2001
MAR COR SERVICES BICARB SYSTEM
FIN
Tank, Holding, Dialysis
203d
Cleared
Jun 06, 2001
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
61d
Cleared
Jun 04, 2001
CONTINUOUS FLOW Y-TUBING
LJH
System, Irrigation, Urological
139d
Cleared
Jun 04, 2001
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
90d
Cleared
Jun 01, 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
KPM
Shunt, Peritoneal
58d
Cleared
May 31, 2001
OSTEOBELL
KNW
Instrument, Biopsy
50d
Cleared
May 24, 2001
HEMODIALYSIS TUBING SETS
FIB
Protector, Transducer, Dialysis
330d
Cleared
May 21, 2001
PELVEX HOMETRAINER
HIR
Perineometer
320d
Cleared
May 16, 2001
MODIFICATION TO MALE TO MALE LUER ADAPTER
KOC
Accessories, Blood Circuit, Hemodialysis
166d
Cleared
May 16, 2001
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
FBK
Endoscopic Injection Needle, Gastroenterology-urology
90d
Cleared
May 15, 2001
DISPOSABLE BENDING CANNULA PR-233Q
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
29d
Cleared
May 15, 2001
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
FDS
Gastroscope And Accessories, Flexible/rigid
29d
Cleared
May 09, 2001
RUSCH MMG/O'NEIL CATHETER
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
86d
Cleared
May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FFK
Lithotriptor, Electro-hydraulic
30d
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