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
8448 Gastroenterology & Urology devices
Cleared
May 05, 1997
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
EZB
Stylet For Catheter, Gastro-urology
10d
Cleared
May 02, 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
224d
Cleared
Apr 30, 1997
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
510d
Cleared
Apr 28, 1997
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
195d
Cleared
Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
KOB
Catheter, Suprapubic (and Accessories)
37d
Cleared
Apr 22, 1997
RESECTOSCOPE CUTTING LOOP ELECTRODE
FAS
Electrode, Electrosurgical, Active, Urological
172d
Cleared
Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
85d
Cleared
Apr 22, 1997
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
OCX
Endoscopic Irrigation/suction System
50d
Cleared
Apr 22, 1997
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
EXJ
Device, Incontinence, Urosheath Type, Sterile
36d
Cleared
Apr 18, 1997
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
504d
Cleared
Apr 17, 1997
VS-100 VIDEO SIGMOIDOSCOPE
FAM
Sigmoidoscope And Accessories, Flexible/rigid
73d
Cleared
Apr 15, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
56d
Cleared
Apr 14, 1997
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
KPM
Shunt, Peritoneal
269d
Cleared
Apr 11, 1997
MICROVASIVE GOLD PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
78d
Cleared
Apr 11, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
FCG
Biopsy Needle
57d
Cleared
Apr 03, 1997
URODYNAMIC ANALYSIS MODULE
FAP
Cystometric Gas (carbon-dioxide) On Hydraulic Device
223d
Cleared
Apr 03, 1997
12 URETEROSCOPES/URETERO-RENOSCOPES
FGB
Ureteroscope And Accessories, Flexible/rigid
190d
Cleared
Apr 02, 1997
STONE DISLODGER, BASKET
FGO
Dislodger, Stone, Flexible
78d
Cleared
Apr 02, 1997
VISTA ILLUMINATION SYSTEM
FFS
Image, Illumination, Fiberoptic, For Endoscope
71d
Cleared
Apr 02, 1997
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
FHA
Clamp, Penile
65d
Cleared
Mar 28, 1997
ERCP CANNULA
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
234d
Cleared
Mar 28, 1997
ULTRATOMERX
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
80d
Cleared
Mar 28, 1997
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
KNW
Instrument, Biopsy
43d
Cleared
Mar 28, 1997
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
GCT
Light Source, Endoscope, Xenon Arc
4d
Cleared
Mar 27, 1997
PNEUMO-MATIC INSUFFLATION NEEDLE
FHO
Pneumoperitoneum Needle
23d
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