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
8406 Gastroenterology & Urology devices
Cleared
Sep 15, 2009
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
428d
Cleared
Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
FCW
Light Source, Fiberoptic, Routine
75d
Cleared
Sep 03, 2009
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
LQR
Dislodger, Stone, Biliary
106d
Cleared
Aug 25, 2009
DIRECTVISION GUIDE SYSTEM
FGC
Urethroscope
83d
Cleared
Aug 21, 2009
AMSURE PVC INTERMITTENT CATHETER
EZD
Catheter, Straight
109d
Cleared
Aug 20, 2009
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
GBM
Catheter, Urethral
136d
Cleared
Aug 12, 2009
FOOTPRINT URINARY DRAINAGE CATHETER
EZD
Catheter, Straight
162d
Cleared
Aug 12, 2009
OMNISURE URETHRAL SLING, MODEL OTK52
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
21d
Cleared
Aug 10, 2009
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
61d
Cleared
Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
217d
Cleared
Aug 07, 2009
FUJINON STERILE OVERTUBES
FED
Endoscopic Access Overtube, Gastroenterology-urology
52d
Cleared
Jul 29, 2009
BULLSEYE BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
370d
Cleared
Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
182d
Cleared
Jul 29, 2009
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
78d
Cleared
Jul 28, 2009
HAEMOBAND MULTI-LIGATOR
FHN
Ligator, Hemorrhoidal
67d
Cleared
Jul 28, 2009
PLS PORTABLE LIGHT SOURCE
NTN
Led Light Source
39d
Cleared
Jul 27, 2009
SONOLITH I-SYS LITHOTRIPER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
231d
Cleared
Jul 23, 2009
INSUFLOW CO2IONSHIELD
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
114d
Cleared
Jul 22, 2009
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
LQR
Dislodger, Stone, Biliary
147d
Cleared
Jul 22, 2009
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
FDI
Snare, Flexible
75d
Cleared
Jul 22, 2009
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
OCW
Endoscopic Tissue Approximation Device
30d
Cleared
Jul 21, 2009
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
FBK
Endoscopic Injection Needle, Gastroenterology-urology
117d
Cleared
Jul 20, 2009
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
MSD
Catheter, Hemodialysis, Implanted
34d
Cleared
Jul 14, 2009
NUTRAC PELVATOR, MODEL PEL 200
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
211d
Cleared
Jul 14, 2009
MINITAPE URETHRAL SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
82d
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