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 18, 2008
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
GCT
Light Source, Endoscope, Xenon Arc
78d
Cleared
Dec 03, 2008
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
KNT
Tubes, Gastrointestinal (and Accessories)
167d
Cleared
Nov 25, 2008
ENTERAL ONLY EXTENSION SET
KNT
Tubes, Gastrointestinal (and Accessories)
74d
Cleared
Nov 19, 2008
SH14 HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
194d
Cleared
Nov 06, 2008
OLYMPUS CHF TYPE V
FBN
Choledochoscope And Accessories, Flexible/rigid
167d
Cleared
Oct 28, 2008
OPTIFLUX F250NR, MODEL 0500325E
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
68d
Cleared
Oct 27, 2008
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
FGE
Stents, Drains And Dilators For The Biliary Ducts
130d
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 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 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
Sep 25, 2008
INJEKT FILIFORM INJECTION NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
43d
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 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
Cleared
Aug 01, 2008
MODIFICATION TO ZILVER 635 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
207d
Cleared
Jul 18, 2008
BLOOD TUBING SETS (STERILE FLUID PATH)
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
119d
Cleared
Jul 18, 2008
ASPIRA PERITONEAL DRAINAGE SYSTEM
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
72d
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