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
Jun 10, 2024
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
FGB
Ureteroscope And Accessories, Flexible/rigid
265d
Cleared
Jun 07, 2024
Disposable Hemostatic Clips
PKL
Hemostatic Metal Clip For The Gi Tract
260d
Cleared
Jun 07, 2024
Uro-G HD Flexible Cystoscope
FAJ
Cystoscope And Accessories, Flexible/rigid
267d
Cleared
Jun 06, 2024
CORTRAK* 2 Enteral Access System (20-0950)
KNT
Tubes, Gastrointestinal (and Accessories)
58d
Cleared
Jun 06, 2024
Wellead® Latex Foley Catheter
MJC
Catheter, Urological (antimicrobial) And Accessories
254d
Cleared
Jun 03, 2024
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
PKL
Hemostatic Metal Clip For The Gi Tract
90d
Cleared
May 31, 2024
multiFlux 1000 (F00012408)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
113d
Cleared
May 31, 2024
Stylus
KNT
Tubes, Gastrointestinal (and Accessories)
205d
Cleared
May 17, 2024
Yoni.Fit Bladder Support
HHW
Pessary, Vaginal
270d
Cleared
May 16, 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
May 10, 2024
Ureterorenoscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
93d
Cleared
May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
100d
Cleared
May 10, 2024
pureFLOW 402 (F00012067)
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
148d
Cleared
May 09, 2024
Tulsa Pro System (Pad-105)
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
98d
Cleared
May 07, 2024
KARL STORZ Monopolar Resectoscopes with HF Cable
FJL
Resectoscope
265d
Cleared
May 06, 2024
Solar Compact (G4-1)
FFX
System, Gastrointestinal Motility (electrical)
125d
Cleared
May 06, 2024
ViSiGi LUX (5332)
KNT
Tubes, Gastrointestinal (and Accessories)
138d
Cleared
May 03, 2024
Sleeved IC 2 Family
EZD
Catheter, Straight
184d
Cleared
May 03, 2024
Tablo® Hemodialysis System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
235d
Cleared
May 02, 2024
Revi™ System
QXM
Implanted Tibial Electrical Urinary Continence Device
118d
Cleared
May 02, 2024
Dragonfly™ Pancreaticobiliary Scope
FBN
Choledochoscope And Accessories, Flexible/rigid
162d
Cleared
May 01, 2024
DuraGraft Vascular Conduit Solution
QEJ
Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
27d
Cleared
May 01, 2024
Percutaneous Nephroscope System
FGA
Kit, Nephroscope
267d
Cleared
Apr 29, 2024
Ultraflex Esophageal NG Stent System
ESW
Prosthesis, Esophageal
137d
Cleared
Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
28d
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