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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5366 Gastroenterology & Urology devices
Cleared
Dec 23, 2016
Zilver 635 Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
53d
Cleared
Dec 21, 2016
Evolution Esophageal Stent System – Partially Covered
ESW
Prosthesis, Esophageal
83d
Cleared
Dec 13, 2016
HPM-6000U
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
146d
Cleared
Nov 29, 2016
Medline ENFit Syringe
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
267d
Cleared
Nov 03, 2016
PleurX Peritoneal Catheter System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
260d
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
Sep 29, 2016
SpeediCath Flex Coude
GBM
Catheter, Urethral
112d
Cleared
Sep 01, 2016
Monoject Enteral Syringe with ENFit Connector
PNR
Enteral Syringes With Enteral Specific Connectors
45d
Cleared
Aug 31, 2016
Erbe’s CO2 Tubing/Cap Sets
FEQ
Pump, Air, Non-manual, For Endoscope
29d
Cleared
Aug 17, 2016
Ambu USR, Ambu M
FAJ
Cystoscope And Accessories, Flexible/rigid
149d
Cleared
Aug 01, 2016
Fuse Endoscopic System with FuseBox Processor
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
181d
Cleared
Jul 19, 2016
EnCor MRI Introducer Set, EnCor Probe Introducer
KNW
Instrument, Biopsy
18d
Cleared
Jun 29, 2016
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
KGE
Forceps, Biopsy, Electric
63d
Cleared
Jun 27, 2016
EndoChoice Water Bottle Cap Irrigation System
FEQ
Pump, Air, Non-manual, For Endoscope
27d
Cleared
Jun 24, 2016
Ultrathane Endoureterotomy Stent Set
FAD
Stent, Ureteral
85d
Cleared
Jun 20, 2016
Lehman Manometry Catheter
FFX
System, Gastrointestinal Motility (electrical)
145d
Cleared
Jun 17, 2016
Monoject
PNR
Enteral Syringes With Enteral Specific Connectors
65d
Cleared
Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
67d
Cleared
Jun 14, 2016
Disposable Hot Biopsy Forceps
KGE
Forceps, Biopsy, Electric
102d
Not Cleared
Jun 03, 2016
WallFlex Biliary RX Fully Covered Stent System RMV
PNB
Biliary Stent System For Benign Strictures
280d
Cleared
May 26, 2016
Seal Single-Use Biopsy Valve
OCX
Endoscopic Irrigation/suction System
30d
Cleared
May 19, 2016
SmartStart Air/Water and Suction Valves
ODC
Endoscope Channel Accessory
97d
Cleared
May 12, 2016
Monoject Enteral Feeding Syringe with ENFit Connector
PNR
Enteral Syringes With Enteral Specific Connectors
86d
Cleared
May 04, 2016
Soehendra Stent Retriever
FGE
Stents, Drains And Dilators For The Biliary Ducts
6d
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