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
9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2287 Gastroenterology & Urology devices
Cleared
Nov 21, 2022
Pentax Medical Valve Set
ODC
Endoscope Channel Accessory
54d
Cleared
Nov 21, 2022
CORE-SNARE
FDI
Snare, Flexible
243d
Cleared
Nov 18, 2022
OCS Lung Donor Flush Set
MSB
System And Accessories, Isolated Heart, Transport And Preservation
88d
Cleared
Nov 18, 2022
Single-Use Flexible Cystoscope
FAJ
Cystoscope And Accessories, Flexible/rigid
170d
Cleared
Nov 17, 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
EZD
Catheter, Straight
168d
Cleared
Nov 14, 2022
Disposable hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
411d
Cleared
Nov 10, 2022
AquaPulse® Irrigation Tubing
OCX
Endoscopic Irrigation/suction System
30d
Cleared
Nov 10, 2022
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
120d
Cleared
Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
FAD
Stent, Ureteral
506d
Cleared
Nov 09, 2022
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
FAJ
Cystoscope And Accessories, Flexible/rigid
111d
Cleared
Nov 08, 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
OCX
Endoscopic Irrigation/suction System
60d
Cleared
Oct 31, 2022
Fresenius Liberty Select Cycler
FKX
System, Peritoneal, Automatic Delivery
90d
Cleared
Oct 31, 2022
Standard Tapered Bougie, 38 Fr.
KNT
Tubes, Gastrointestinal (and Accessories)
108d
Cleared
Oct 27, 2022
2008T BlueStar Hemodailysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
Cleared
Oct 27, 2022
Mobility+ Enteral Feeding System
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
51d
Cleared
Oct 26, 2022
EsoCheck Cell Collection Device
EOX
Esophagoscope (flexible Or Rigid)
83d
Cleared
Oct 21, 2022
Enteral Transition Adaptor
PIO
Enteral Specific Transition Connectors
274d
Cleared
Oct 18, 2022
E-Z Chek Chlorine Residual Test Strips (K100-0101B)
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
89d
Cleared
Oct 13, 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
KOD
Catheter, Urological
213d
Cleared
Oct 07, 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
OCX
Endoscopic Irrigation/suction System
155d
Cleared
Oct 05, 2022
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
FGB
Ureteroscope And Accessories, Flexible/rigid
26d
Cleared
Oct 03, 2022
Elastic Traction System
QSW
Endoscopic Traction Device
60d
Cleared
Sep 30, 2022
DoubleChek DC-1001
KNT
Tubes, Gastrointestinal (and Accessories)
431d
Cleared
Sep 28, 2022
EndoGI S-Path Biliary Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Sep 27, 2022
Clean Connecting Tube
OCX
Endoscopic Irrigation/suction System
194d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices