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
Dec 18, 2001
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
KNW
Instrument, Biopsy
168d
Cleared
Dec 12, 2001
BIOSPEED
FCG
Biopsy Needle
90d
Cleared
Dec 12, 2001
JAMSHIDI BIOPSY NEEDLE
FCG
Biopsy Needle
90d
Cleared
Dec 12, 2001
SECURCUT ASPIRATION BIOPSY NEEDLE
FCG
Biopsy Needle
90d
Cleared
Dec 11, 2001
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
123d
Cleared
Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
MND
Ligator, Esophageal
90d
Cleared
Dec 10, 2001
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
FGB
Ureteroscope And Accessories, Flexible/rigid
180d
Cleared
Dec 07, 2001
EXCEL A.V FISUTAL NEEDLE SET
FIE
Needle, Fistula
88d
Cleared
Dec 07, 2001
DAYLITE XENON LIGHT SOURCES
GCT
Light Source, Endoscope, Xenon Arc
14d
Cleared
Dec 06, 2001
MEDIGROUP KEY TUBE
FJS
Catheter, Peritoneal, Long-term Indwelling
90d
Cleared
Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
FKX
System, Peritoneal, Automatic Delivery
90d
Cleared
Nov 30, 2001
SERIM BLOOD LEAK TEST STRIP-2
FJD
Detector, Leak, Blood
147d
Cleared
Nov 28, 2001
DISPOSABLE STORAGE CAP
FJI
Dialyzer, Capillary, Hollow Fiber
294d
Cleared
Nov 28, 2001
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
LJH
System, Irrigation, Urological
272d
Cleared
Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
162d
Cleared
Nov 20, 2001
CLIRANS E-SERIES DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
27d
Cleared
Nov 19, 2001
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
FAJ
Cystoscope And Accessories, Flexible/rigid
80d
Cleared
Nov 16, 2001
FANELLI BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
261d
Cleared
Nov 16, 2001
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
LJE
Catheter, Nephrostomy
218d
Cleared
Nov 16, 2001
TWINTRODE ELC 134 ELECTRODE
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
88d
Cleared
Nov 16, 2001
HILL-ROM PRIMAVIEW MONITOR SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
8d
Cleared
Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
FGE
Stents, Drains And Dilators For The Biliary Ducts
91d
Cleared
Nov 14, 2001
ICE BATON
LKX
Device, Thermal, Hemorrhoids
90d
Cleared
Nov 09, 2001
VT-1
LKY
Device, External Penile Rigidity
88d
Cleared
Nov 09, 2001
SE-200
LKY
Device, External Penile Rigidity
88d
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