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
8389 Gastroenterology & Urology devices
Cleared
Oct 07, 2013
ESOFLIP BALLOON DILATION CATHETER
PID
Esophageal Dilator Balloon With Or Without Electrode Sensors
73d
Cleared
Oct 04, 2013
INNER PEACE
HIR
Perineometer
387d
Cleared
Oct 03, 2013
DISPOSABLE SILICONE FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
185d
Cleared
Oct 03, 2013
THERMOCHEM HT-2000
MLW
Warmer, Peritoneal Dialysate
125d
Cleared
Sep 26, 2013
PRECISION ONE LIFECARE
MNW
Analyzer, Body Composition
174d
Cleared
Sep 23, 2013
DESARA MESH, DESARA BLUE
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
82d
Cleared
Sep 23, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
27d
Cleared
Sep 20, 2013
MROZ REVERSE OSMOSIS SYSTEM
FIP
Subsystem, Water Purification
109d
Cleared
Sep 19, 2013
APD LUER-LOCK ADAPTER
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
265d
Cleared
Sep 18, 2013
TRANSTEK GLASS BODY FAT ANALYZER
MNW
Analyzer, Body Composition
126d
Cleared
Sep 18, 2013
MEDLINE ANTI-REFLUX VALVE
FEG
Tube, Double Lumen For Intestinal Decompression And/or Intubation
55d
Cleared
Sep 13, 2013
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM
PFH
Venous Window Needle Guide
168d
Not Cleared
Sep 13, 2013
UROLIFT SYSTEM
PEW
Implantable Transprostatic Tissue Retractor System
190d
Cleared
Sep 09, 2013
FRESENIUS LIBERTY CYCLER
FKX
System, Peritoneal, Automatic Delivery
290d
Cleared
Aug 30, 2013
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
161d
Cleared
Aug 29, 2013
FRESENIUS DRY ACID DISSOLUTION UNITS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
87d
Cleared
Aug 29, 2013
EVIS EXERA III VIDEO SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
73d
Cleared
Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
51d
Cleared
Aug 23, 2013
AUTOBAND LIGATOR
MND
Ligator, Esophageal
10d
Cleared
Aug 22, 2013
SIM
KPN
Alarm, Conditioned Response Enuresis
139d
Cleared
Aug 20, 2013
GUARDIAN URETHRAL SHEATH
KNY
Accessories, Catheter, G-u
62d
Cleared
Aug 16, 2013
PERF-GEN PULSATILE PERFUSION SOLUTION
KDL
Set, Perfusion, Kidney, Disposable
429d
Cleared
Aug 16, 2013
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
KNT
Tubes, Gastrointestinal (and Accessories)
123d
Cleared
Aug 12, 2013
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
238d
Cleared
Aug 12, 2013
ELECTROMAGNETIC TRANSMITTING STYLET
KNT
Tubes, Gastrointestinal (and Accessories)
76d
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