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
8420 Gastroenterology & Urology devices
Cleared
Jul 11, 2005
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
ESW
Prosthesis, Esophageal
21d
Cleared
Jul 08, 2005
SINGLE USE BALLOON DILATOR MAXPASSTM
FGE
Stents, Drains And Dilators For The Biliary Ducts
130d
Cleared
Jul 08, 2005
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
29d
Cleared
Jun 28, 2005
AMSURE 100% SILICONE FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
63d
Cleared
Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
15d
Cleared
Jun 24, 2005
NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
114d
Cleared
Jun 17, 2005
PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
Cleared
Jun 16, 2005
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
FAS
Electrode, Electrosurgical, Active, Urological
66d
Cleared
Jun 16, 2005
SONOTIP II ULTRASOUND NEEDLE SYSTEM
FCG
Biopsy Needle
31d
Cleared
Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
KNW
Instrument, Biopsy
22d
Cleared
Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
FED
Endoscopic Access Overtube, Gastroenterology-urology
9d
Cleared
Jun 13, 2005
SERIM DIALYSATE MONITOR TEST STRIP
NTZ
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
222d
Cleared
Jun 13, 2005
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
84d
Cleared
Jun 09, 2005
OLPUR DIALYZER, MODEL HD 190
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
92d
Cleared
Jun 08, 2005
FRESENIUS ART HEMOADSORPTION SYSTEM
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
121d
Cleared
Jun 08, 2005
REXEED SERIES DIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Jun 03, 2005
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
FKT
System, Dialysate Delivery, Sorbent Regenerated
158d
Cleared
Jun 03, 2005
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
EZD
Catheter, Straight
151d
Cleared
Jun 03, 2005
IMBIBE BONE MARROW ASPIRATION NEEDLE
KNW
Instrument, Biopsy
66d
Cleared
May 27, 2005
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
FLD
Apparatus, Hemoperfusion, Sorbent
596d
Cleared
May 27, 2005
PROCON2
KNT
Tubes, Gastrointestinal (and Accessories)
261d
Cleared
May 27, 2005
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
FJI
Dialyzer, Capillary, Hollow Fiber
172d
Cleared
May 27, 2005
OMNITECH FULGURATING ELECTRODE
FAS
Electrode, Electrosurgical, Active, Urological
94d
Cleared
May 26, 2005
U-BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
50d
Cleared
May 23, 2005
REPROCESSED ENDOSCOPIC TROCAR
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
145d
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