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
May 18, 2012
SRS ENDOSCOPIC STAPLING SYSTEM
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
108d
Cleared
May 17, 2012
EVOLUTION COLONIC STENT SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
171d
Cleared
May 17, 2012
PRESTO BREAST BIOPSY DEVICE
KNW
Instrument, Biopsy
94d
Cleared
May 16, 2012
CLEARPATH LOWER GI
FDF
Colonoscope And Accessories, Flexible/rigid
216d
Cleared
May 16, 2012
CLEARPATH UPPER GI
FDS
Gastroscope And Accessories, Flexible/rigid
202d
Cleared
May 14, 2012
ROCAMED ROCAUS PLATINUM
KNY
Accessories, Catheter, G-u
116d
Cleared
May 11, 2012
DOBBHOFF DUAL PORT FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
255d
Cleared
May 11, 2012
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
OCT
Anti Fog Solution And Accessories, Endoscopy
53d
Cleared
May 08, 2012
OPHIRA MINI SLING SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
449d
Cleared
May 03, 2012
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
LKX
Device, Thermal, Hemorrhoids
142d
Cleared
May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
30d
Cleared
Apr 27, 2012
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
260d
Cleared
Apr 27, 2012
ENDOGATOR ADVANTAGE IRRIGATION PUMP
OCX
Endoscopic Irrigation/suction System
189d
Not Cleared
Apr 27, 2012
PROSTATE MECHANICAL IMAGER
OQT
Prostate Lesion, Documentation, System
707d
Cleared
Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
255d
Cleared
Apr 24, 2012
APLAN A.V. FISTULA NEEDLE SET
FIE
Needle, Fistula
217d
Cleared
Apr 24, 2012
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
70d
Cleared
Apr 20, 2012
SAFETY SCREW CONNECTOR
KNT
Tubes, Gastrointestinal (and Accessories)
123d
Cleared
Apr 19, 2012
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
KNT
Tubes, Gastrointestinal (and Accessories)
90d
Cleared
Apr 17, 2012
LOFRIC SINGLE USE URINARY CATHETER
EZD
Catheter, Straight
148d
Cleared
Apr 09, 2012
WEIGHT AND BODY FAT SCALE SHINE BS0105
MNW
Analyzer, Body Composition
258d
Cleared
Apr 06, 2012
IMAGE1 GI CCU MODEL 22203020-114
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
268d
Cleared
Apr 04, 2012
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
OCX
Endoscopic Irrigation/suction System
335d
Cleared
Apr 04, 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
FGB
Ureteroscope And Accessories, Flexible/rigid
313d
Cleared
Apr 04, 2012
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
MPB
Catheter, Hemodialysis, Non-implanted
30d
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