FDA 510(k) Gastroenterology & Urology Devices
About Gastroenterology & Urology Devices
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
9824
Total
9777
Cleared
130d
Avg days
1976
Since
610 Gastroenterology & Urology devices
Cleared
Jul 24, 2024
CADDIE
QNP
Gastrointesinal Lesion Software Detection System
201d
Cleared
Jul 16, 2024
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
FGB
Ureteroscope And Accessories, Flexible/rigid
232d
Cleared
Jul 12, 2024
Endoscopic Video Image Processor (RP-IPD-V2000EF)
FAJ
Cystoscope And Accessories, Flexible/rigid
45d
Cleared
Jul 12, 2024
HemoCare Bicarbonate Concentrate Set (BCS)
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
99d
Cleared
Jul 12, 2024
“MoFi” Cell Culture Basal Medium
NDS
Media, Culture, Ex Vivo, Tissue And Cell
164d
Cleared
Jul 12, 2024
Single Use Hemoclips
PKL
Hemostatic Metal Clip For The Gi Tract
197d
Cleared
Jul 12, 2024
HemoCare Hemodialysis System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
249d
Cleared
Jul 03, 2024
Blue Eye
PLL
Submucosal Injection Agent
30d
Cleared
Jul 03, 2024
SKOUT® system
QNP
Gastrointesinal Lesion Software Detection System
36d
Cleared
Jul 03, 2024
Gastric Alimetry
MYE
System, Electrogastrography (egg)
89d
Cleared
Jul 03, 2024
Disposable Enteral Feeding Sets
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
177d
Cleared
Jul 01, 2024
Single-use Video Ureterorenoscope (SVU-220US)
FGB
Ureteroscope And Accessories, Flexible/rigid
24d
Cleared
Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000)
FGB
Ureteroscope And Accessories, Flexible/rigid
27d
Cleared
Jul 01, 2024
StarFormer
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
192d
Cleared
Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
FIB
Protector, Transducer, Dialysis
158d
Cleared
Jun 27, 2024
Pathfinder® CR System
FED
Endoscopic Access Overtube, Gastroenterology-urology
91d
Cleared
Jun 24, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
FGB
Ureteroscope And Accessories, Flexible/rigid
224d
Cleared
Jun 21, 2024
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
FAJ
Cystoscope And Accessories, Flexible/rigid
105d
Cleared
Jun 21, 2024
GERDX-System
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
267d
Cleared
Jun 19, 2024
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
FDS
Gastroscope And Accessories, Flexible/rigid
271d
Cleared
Jun 14, 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
FGE
Stents, Drains And Dilators For The Biliary Ducts
262d
Cleared
Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
FDA
Enteroscope And Accessories
258d
Cleared
Jun 13, 2024
AquaBplus
FIP
Subsystem, Water Purification
266d
Cleared
Jun 12, 2024
PLASMA EDGE System
FAS
Electrode, Electrosurgical, Active, Urological
112d
Cleared
Jun 10, 2024
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)
FAJ
Cystoscope And Accessories, Flexible/rigid
130d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices