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
612 Gastroenterology & Urology devices
Cleared
Apr 23, 2024
Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
119d
Cleared
Apr 19, 2024
SKOUT® system
QNP
Gastrointesinal Lesion Software Detection System
29d
Cleared
Apr 17, 2024
TraumaGuard Intra-abdominal Pressure Sensing System
EZL
Catheter, Retention Type, Balloon
100d
Cleared
Apr 17, 2024
Enteral Feeding Sets
KNT
Tubes, Gastrointestinal (and Accessories)
103d
Cleared
Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
FDT
Duodenoscope And Accessories, Flexible/rigid
130d
Cleared
Apr 15, 2024
Folysil Silicone Catheter
EZL
Catheter, Retention Type, Balloon
192d
Cleared
Apr 12, 2024
Mobility+ Enteral Feeding System OTC
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
200d
Cleared
Apr 12, 2024
Disposable Injection Needles
FBK
Endoscopic Injection Needle, Gastroenterology-urology
262d
Cleared
Apr 05, 2024
Ambu® aScope™ Gastro Large
FDS
Gastroscope And Accessories, Flexible/rigid
199d
Cleared
Apr 04, 2024
Agile Esophageal Stent System
ESW
Prosthesis, Esophageal
122d
Cleared
Apr 03, 2024
Uresta®
HHW
Pessary, Vaginal
152d
Not Cleared
Apr 02, 2024
Sepsis ImmunoScore
SAK
Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
333d
Cleared
Mar 29, 2024
Disposable Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
198d
Cleared
Mar 25, 2024
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard)
FGB
Ureteroscope And Accessories, Flexible/rigid
178d
Cleared
Mar 22, 2024
Esophageal TTS Stent
ESW
Prosthesis, Esophageal
28d
Cleared
Mar 22, 2024
RELIEF™ Ureteral Stent Kit
FAD
Stent, Ureteral
185d
Cleared
Mar 22, 2024
Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
ODC
Endoscope Channel Accessory
255d
Cleared
Mar 21, 2024
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
GEX
Powered Laser Surgical Instrument
210d
Cleared
Mar 19, 2024
Disposable Dual Action Tissue Closure Device
PKL
Hemostatic Metal Clip For The Gi Tract
116d
Cleared
Mar 15, 2024
Endorail
ODC
Endoscope Channel Accessory
225d
Cleared
Mar 14, 2024
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
184d
Cleared
Mar 12, 2024
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
263d
Cleared
Mar 08, 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
MQR
Stent, Colonic, Metallic, Expandable
78d
Cleared
Mar 08, 2024
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
FBK
Endoscopic Injection Needle, Gastroenterology-urology
177d
Cleared
Mar 08, 2024
Ultrasonic Gastrovideoscope
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
261d
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