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
8429 Gastroenterology & Urology devices
Cleared
May 06, 2002
PPD BALLOON DILATATION CATHETER
KNT
Tubes, Gastrointestinal (and Accessories)
90d
Cleared
May 03, 2002
INDWELLING FECAL MANAGEMENT SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
301d
Cleared
May 02, 2002
GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
90d
Cleared
May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
FAJ
Cystoscope And Accessories, Flexible/rigid
30d
Cleared
Apr 29, 2002
REPROCESSED GUIDEWIRES
NML
Catheter, Biliary, Reprocessed
264d
Cleared
Apr 29, 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
193d
Cleared
Apr 26, 2002
SIIS#1 TISSUE SUSPENSION SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
53d
Cleared
Apr 23, 2002
DIASOL-BICARB
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
90d
Cleared
Apr 17, 2002
NXSTAGE THERAPY SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Apr 16, 2002
INTRASTENT LD (LARGE DIAMETER) STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
56d
Cleared
Apr 12, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
FHN
Ligator, Hemorrhoidal
29d
Cleared
Apr 11, 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
202d
Cleared
Apr 10, 2002
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
90d
Cleared
Apr 09, 2002
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
FGB
Ureteroscope And Accessories, Flexible/rigid
235d
Cleared
Apr 09, 2002
STRATASIS SLING KIT
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
40d
Cleared
Apr 04, 2002
BIOSUC
KNW
Instrument, Biopsy
199d
Cleared
Apr 04, 2002
VT-1
LKY
Device, External Penile Rigidity
77d
Cleared
Apr 04, 2002
SUPPORT SLEEVE
LKY
Device, External Penile Rigidity
69d
Cleared
Apr 03, 2002
CARIS MINITOME BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
90d
Cleared
Apr 03, 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
82d
Cleared
Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Mar 29, 2002
O'REGAN DISPOSABLE ANOSCOPE
FER
Anoscope And Accessories
25d
Cleared
Mar 28, 2002
MODIFICATION TO SPARC SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
27d
Cleared
Mar 26, 2002
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
434d
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