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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5358 Gastroenterology & Urology devices
Cleared
Jun 14, 2023
Niti-S Duodenal Stent
MUM
Stent, Metallic, Expandable, Duodenal
264d
Not Cleared
Jun 09, 2023
Eroxon
QWW
Non-medicated Topical Formulation For Treatment Of Erectile Dysfunction.
231d
Cleared
Jun 02, 2023
i3 ONE (203100-S)
NHV
System, Water Purification, General Medical Use
267d
Cleared
May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
526d
Cleared
May 30, 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
FCG
Biopsy Needle
60d
Cleared
May 26, 2023
Niti-S Biliary Speed D Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
172d
Cleared
May 22, 2023
PVC Hydrophilic Urethral Catheter
EZD
Catheter, Straight
434d
Cleared
May 19, 2023
GI Genius System 100 and GI Genius System 200
QNP
Gastrointesinal Lesion Software Detection System
28d
Cleared
May 19, 2023
PrevisEA Device
DQD
Stethoscope, Electronic
60d
Cleared
May 18, 2023
Single-Use Flexible Ureteroscope
FGB
Ureteroscope And Accessories, Flexible/rigid
113d
Cleared
May 11, 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
423d
Cleared
May 05, 2023
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
EZN
Dilator, Catheter, Ureteral
414d
Cleared
May 04, 2023
SOZO Pro
QJB
Adjunct Monitor, Protein Calorie Malnutrition
66d
Cleared
May 04, 2023
SOZO Pro
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
66d
Cleared
May 04, 2023
SimPro™ Now, GentleCath™ Hydrophilic
EZD
Catheter, Straight
140d
Cleared
May 03, 2023
Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
265d
Cleared
May 02, 2023
ASEPT Peritoneal Drainage System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
315d
Cleared
May 01, 2023
vPATCH
QRC
Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation
150d
Cleared
Apr 27, 2023
Gastric Alimetry System
MYE
System, Electrogastrography (egg)
170d
Cleared
Apr 26, 2023
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
243d
Cleared
Apr 25, 2023
MiVu™ Esophageal Endo Cap
QIS
Esophageal, Mucosal, Electrical Characterization
106d
Cleared
Apr 20, 2023
Flexible Video-Choledochoscope System
FBN
Choledochoscope And Accessories, Flexible/rigid
266d
Cleared
Apr 14, 2023
EndoflipTM 300
FFX
System, Gastrointestinal Motility (electrical)
123d
Cleared
Apr 13, 2023
NaviCam Xpress Stomach System, NaviCam Xpress System
QKZ
Magnetically Maneuvered Capsule Endoscopy System
31d
Cleared
Apr 07, 2023
SKOUT® system
QNP
Gastrointesinal Lesion Software Detection System
29d
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