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
8412 Gastroenterology & Urology devices
Cleared
Oct 27, 2008
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
61d
Cleared
Oct 27, 2008
COOK WIRE GUIDES
OCY
Endoscopic Guidewire, Gastroenterology-urology
55d
Cleared
Oct 27, 2008
UC-CARE POSITIONING SYSTEM
EZL
Catheter, Retention Type, Balloon
27d
Cleared
Oct 24, 2008
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
MNW
Analyzer, Body Composition
141d
Cleared
Oct 23, 2008
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
LJE
Catheter, Nephrostomy
203d
Cleared
Oct 23, 2008
AMSELF CLOSED CATHETERIZATION SYSTEM
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
27d
Cleared
Oct 21, 2008
XCHF-T160 VIDEOSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
46d
Cleared
Oct 20, 2008
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FAE
Prosthesis, Penile
97d
Cleared
Oct 17, 2008
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
37d
Cleared
Oct 15, 2008
NXSTAGE PUREFLOW SL
FKR
Subsystem, Proportioning
197d
Cleared
Oct 15, 2008
VACORA VACUUM ASSISTED BIOPSY SYSTEM
KNW
Instrument, Biopsy
30d
Cleared
Oct 10, 2008
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
FBO
Cystourethroscope
84d
Cleared
Oct 09, 2008
PERFADEX WITH THAM
MSB
System And Accessories, Isolated Heart, Transport And Preservation
87d
Cleared
Oct 08, 2008
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
EZL
Catheter, Retention Type, Balloon
13d
Cleared
Oct 03, 2008
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
193d
Cleared
Oct 03, 2008
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
31d
Cleared
Oct 01, 2008
NEOMED POLYURETHANE FEEDING TUBE
FPD
Tube, Feeding
55d
Cleared
Sep 25, 2008
CHOOSTENT
ESW
Prosthesis, Esophageal
423d
Cleared
Sep 25, 2008
INJEKT FILIFORM INJECTION NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
43d
Cleared
Sep 19, 2008
MODIFIED ENDO STICH
OCW
Endoscopic Tissue Approximation Device
7d
Cleared
Sep 17, 2008
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
100d
Cleared
Sep 12, 2008
KEGEL8 PELVIC EXERCISER, MODEL OPH 400
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
108d
Cleared
Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
ESW
Prosthesis, Esophageal
211d
Cleared
Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
114d
Cleared
Aug 26, 2008
TAXI ENDOSCOPIC GUIDEWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
70d
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