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
Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
FGA
Kit, Nephroscope
90d
Cleared
Dec 07, 2007
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
EZL
Catheter, Retention Type, Balloon
283d
Cleared
Dec 07, 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
EZL
Catheter, Retention Type, Balloon
281d
Cleared
Nov 20, 2007
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
FFS
Image, Illumination, Fiberoptic, For Endoscope
74d
Cleared
Nov 14, 2007
RESOLVE BILIARY DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
331d
Cleared
Nov 09, 2007
SPEEDICATH COMPACT
GBM
Catheter, Urethral
39d
Cleared
Nov 08, 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
461d
Cleared
Nov 02, 2007
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
239d
Cleared
Nov 01, 2007
MODULARIS VARIOSTAR
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
223d
Cleared
Oct 04, 2007
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
72d
Cleared
Sep 14, 2007
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
319d
Cleared
Sep 07, 2007
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
MPB
Catheter, Hemodialysis, Non-implanted
136d
Cleared
Aug 30, 2007
STORZ SLX-F2 STORM TOUCH
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
182d
Cleared
Aug 24, 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
109d
Cleared
Aug 24, 2007
AMS MINIARC SLING SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
45d
Cleared
Aug 08, 2007
HF JUNIOR HEMOFILTER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
91d
Cleared
Jul 18, 2007
MEDLINE LATEX FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
57d
Cleared
Jun 29, 2007
SPYCATCH STONE RETRIEVAL BASKET
LQR
Dislodger, Stone, Biliary
74d
Cleared
Jun 15, 2007
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
28d
Cleared
Jun 11, 2007
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
NSI
System, Imaging, Esophageal, Wireless, Capsule
47d
Cleared
May 31, 2007
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
78d
Cleared
May 22, 2007
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
ODA
Endoscopic Central Control Unit
57d
Cleared
May 08, 2007
RESONANCE METALLIC URETERAL STENT
FAD
Stent, Ureteral
141d
Cleared
May 07, 2007
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
76d
Cleared
Apr 30, 2007
DELTACUT (APPARATUS AND CANNULA)
KNW
Instrument, Biopsy
187d
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