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
602 Gastroenterology & Urology devices
Cleared
Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
FDS
Gastroscope And Accessories, Flexible/rigid
237d
Cleared
Dec 12, 2025
Revi System
QXM
Implanted Tibial Electrical Urinary Continence Device
134d
Cleared
Dec 05, 2025
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
FFX
System, Gastrointestinal Motility (electrical)
109d
Cleared
Dec 05, 2025
Gastric Alimetry
MYE
System, Electrogastrography (egg)
119d
Cleared
Dec 05, 2025
Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
FAS
Electrode, Electrosurgical, Active, Urological
213d
Cleared
Dec 02, 2025
Disposable Endoscopic Injection Needles
FBK
Endoscopic Injection Needle, Gastroenterology-urology
155d
Cleared
Nov 26, 2025
Vanquish Water Vapor Ablation Device
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
118d
Cleared
Nov 25, 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
76d
Cleared
Nov 24, 2025
BCM2-Body Composition Monitor
DSB
Plethysmograph, Impedance
266d
Cleared
Nov 19, 2025
Focal One®
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
152d
Cleared
Nov 18, 2025
Miniature Telescope for Urology (27033AA)
FGB
Ureteroscope And Accessories, Flexible/rigid
49d
Cleared
Nov 14, 2025
AquaC UNO H
FIP
Subsystem, Water Purification
269d
Cleared
Nov 12, 2025
Hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
114d
Cleared
Oct 31, 2025
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
FDS
Gastroscope And Accessories, Flexible/rigid
211d
Cleared
Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
FGB
Ureteroscope And Accessories, Flexible/rigid
218d
Cleared
Oct 30, 2025
HANAROSTENT Esophagus Upper (CCC)
ESW
Prosthesis, Esophageal
30d
Cleared
Oct 30, 2025
Niti-S Esophageal Stent
ESW
Prosthesis, Esophageal
342d
Cleared
Oct 24, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
FCG
Biopsy Needle
64d
Cleared
Oct 23, 2025
UV5000W Handle
FAJ
Cystoscope And Accessories, Flexible/rigid
24d
Cleared
Oct 21, 2025
Disposable Balloon Catheter (B5-2Q)
FGE
Stents, Drains And Dilators For The Biliary Ducts
250d
Cleared
Oct 17, 2025
X9 Ultrasound System
SGH
Ultrasound Imaging For Vascular Access For Hemodialysis
140d
Cleared
Oct 17, 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
203d
Cleared
Oct 17, 2025
Biopsy Port Adapter
ODC
Endoscope Channel Accessory
269d
Not Cleared
Oct 17, 2025
Modius Lean
SFW
Cranial Electrotherapy Stimulator For Weight Management
303d
Cleared
Oct 16, 2025
Injector Force Max Single Use Injector (NM-400L)
FBK
Endoscopic Injection Needle, Gastroenterology-urology
90d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices