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
8395 Gastroenterology & Urology devices
Cleared
Feb 13, 2012
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
GBM
Catheter, Urethral
270d
Cleared
Feb 10, 2012
CRE DITATATION BALLON
FGE
Stents, Drains And Dilators For The Biliary Ducts
126d
Cleared
Feb 06, 2012
NAVIAID ICVI-F,S,B,R DEVICE
ODC
Endoscope Channel Accessory
199d
Cleared
Feb 02, 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Jan 26, 2012
BICARB MIXING AND DISTRIBUTION SYSTEM
FIN
Tank, Holding, Dialysis
156d
Cleared
Jan 25, 2012
ENDOCHOICE WATER BOTTLE CAP SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
141d
Cleared
Jan 20, 2012
SPECTRA OPTIA APHERESIS SYSTEM
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
58d
Cleared
Jan 12, 2012
LUCEA LED SURGICAL LIGHT SYSTEM
NTN
Led Light Source
29d
Cleared
Jan 10, 2012
CORTRAK ENTERAL ACCESS DEVICE
KNT
Tubes, Gastrointestinal (and Accessories)
57d
Cleared
Jan 06, 2012
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
ODA
Endoscopic Central Control Unit
255d
Cleared
Dec 30, 2011
HANAROSTENT BILIARY (NNN)
FGE
Stents, Drains And Dilators For The Biliary Ducts
249d
Cleared
Dec 30, 2011
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
121d
Cleared
Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
119d
Cleared
Dec 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Dec 20, 2011
KIM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
434d
Cleared
Dec 19, 2011
ACEM
FFZ
Cord, Electric, For Endoscope
252d
Cleared
Dec 16, 2011
MED GRAVITY SET, IMED PUMP SET
KNT
Tubes, Gastrointestinal (and Accessories)
452d
Cleared
Dec 16, 2011
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
MPB
Catheter, Hemodialysis, Non-implanted
269d
Cleared
Dec 08, 2011
SPLIT CATH III
MSD
Catheter, Hemodialysis, Implanted
178d
Cleared
Nov 30, 2011
DESARA MINI
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
373d
Cleared
Nov 29, 2011
SURECORE BIOPSY DEVICE
KNW
Instrument, Biopsy
432d
Cleared
Nov 21, 2011
CHIBA SONO
KNW
Instrument, Biopsy
21d
Cleared
Nov 18, 2011
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
MPB
Catheter, Hemodialysis, Non-implanted
415d
Cleared
Nov 08, 2011
ENTERAL FEEDING BAG AND SETS
KNT
Tubes, Gastrointestinal (and Accessories)
412d
Cleared
Nov 04, 2011
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
592d
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