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
8377 Gastroenterology & Urology devices
Cleared
Dec 21, 2016
Evolution Esophageal Stent System – Partially Covered
ESW
Prosthesis, Esophageal
83d
Cleared
Dec 21, 2016
Sonablate
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
260d
Cleared
Dec 13, 2016
HPM-6000U
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
146d
Cleared
Dec 13, 2016
Matrix Pre-Treatment Controller
FIP
Subsystem, Water Purification
161d
Cleared
Dec 09, 2016
Arc EndoCuff and Arc EndoCuff Vision
FED
Endoscopic Access Overtube, Gastroenterology-urology
126d
Cleared
Dec 06, 2016
DiLumen Endolumenal Interventional Platform
FDF
Colonoscope And Accessories, Flexible/rigid
98d
Cleared
Nov 30, 2016
TubeClear Control Box and Clearing Stem
KNT
Tubes, Gastrointestinal (and Accessories)
26d
Cleared
Nov 29, 2016
Medline ENFit Syringe
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
267d
Cleared
Nov 22, 2016
ConvertX Nephroureteral Stent System
FAD
Stent, Ureteral
200d
Cleared
Nov 22, 2016
U&U Enteral Syringe
PNR
Enteral Syringes With Enteral Specific Connectors
239d
Cleared
Nov 18, 2016
RAPIDO HOLLOW-FIBRE DIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
263d
Cleared
Nov 15, 2016
Tablo Console
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
230d
Cleared
Nov 14, 2016
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
73d
Cleared
Nov 03, 2016
PleurX Peritoneal Catheter System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
260d
Cleared
Oct 27, 2016
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
KNW
Instrument, Biopsy
265d
Cleared
Oct 21, 2016
CapsoCam Plus (SV-3) Capsule Endoscope System
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
115d
Cleared
Oct 21, 2016
NOSOGARD FILTERS
NHV
System, Water Purification, General Medical Use
295d
Cleared
Oct 20, 2016
Rockwell Medical CitraPure Acid Concetrate
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
206d
Cleared
Oct 18, 2016
Fujifilm Endoscope Models EC-600HL and EC-600LS
FDF
Colonoscope And Accessories, Flexible/rigid
28d
Cleared
Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
44d
Cleared
Oct 12, 2016
ClearPetra Suction-Evacuation Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
175d
Cleared
Oct 12, 2016
FTRD System Set
PKL
Hemostatic Metal Clip For The Gi Tract
306d
Cleared
Sep 29, 2016
Nexcore GI Insufflator
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
41d
Cleared
Sep 29, 2016
SpeediCath Flex Coude
GBM
Catheter, Urethral
112d
Not Cleared
Sep 26, 2016
Sensor Monitored Alimentary Restriction Therapy (SMART) Device
ONY
Oral Removable Retainer For Weight Management
423d
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