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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5367 Gastroenterology & Urology devices
Cleared
Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
106d
Cleared
Oct 17, 2014
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
FAD
Stent, Ureteral
148d
Cleared
Oct 17, 2014
EXPEL APD DRAINAGE CATHETER SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
149d
Cleared
Sep 30, 2014
FUSE COLONOSCOPY SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
109d
Cleared
Sep 24, 2014
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
316d
Cleared
Sep 11, 2014
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
FIE
Needle, Fistula
255d
Cleared
Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
257d
Cleared
Sep 05, 2014
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
KNW
Instrument, Biopsy
86d
Cleared
Sep 04, 2014
IVAS 8 GAUGE BONE BIOPSY KIT
KNW
Instrument, Biopsy
73d
Cleared
Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
70d
Cleared
Aug 22, 2014
EPX-4440HD DIGITAL VIDEO PROCESSOR
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
212d
Cleared
Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
KOC
Accessories, Blood Circuit, Hemodialysis
90d
Cleared
Jul 30, 2014
LIBERTY PDX CYCLER
FKX
System, Peritoneal, Automatic Delivery
89d
Cleared
Jul 30, 2014
ENDOLED
NTN
Led Light Source
275d
Cleared
Jul 24, 2014
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
FED
Endoscopic Access Overtube, Gastroenterology-urology
142d
Cleared
Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
FDI
Snare, Flexible
119d
Cleared
Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
275d
Cleared
Jun 18, 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
26d
Cleared
Jun 16, 2014
BONASTENT BILIARY
FGE
Stents, Drains And Dilators For The Biliary Ducts
82d
Cleared
Jun 16, 2014
NXSTAGE EXPRESS FLUID WARMER
FLA
Monitor, Temperature, Dialysis
97d
Cleared
Jun 16, 2014
PILLING ESOPHAGEAL BOUGIES
FAT
Bougie, Esophageal, And Gastrointestinal, Gastro-urology
216d
Cleared
Jun 11, 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
FGB
Ureteroscope And Accessories, Flexible/rigid
28d
Cleared
May 23, 2014
WALLFLEX BILIARY RX STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
73d
Cleared
May 19, 2014
NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
76d
Cleared
May 15, 2014
NXSTAGE PUREFLOW SL
FKR
Subsystem, Proportioning
70d
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