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
9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2315 Gastroenterology & Urology devices
Cleared
May 10, 2018
2008T BlueStar Hemodialysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
132d
Cleared
May 08, 2018
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
FDS
Gastroscope And Accessories, Flexible/rigid
223d
Cleared
May 04, 2018
Caldera Medical Transobturator Helical Introducer, Left
PWJ
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
246d
Cleared
May 03, 2018
Repris Bladder Injection System
FBK
Endoscopic Injection Needle, Gastroenterology-urology
98d
Cleared
May 02, 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
EZN
Dilator, Catheter, Ureteral
119d
Cleared
May 01, 2018
Liberty Cycler Set
FKX
System, Peritoneal, Automatic Delivery
147d
Cleared
May 01, 2018
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
FGE
Stents, Drains And Dilators For The Biliary Ducts
215d
Cleared
Apr 26, 2018
Beacon EUS Access System
FCG
Biopsy Needle
111d
Cleared
Apr 19, 2018
Ultramatrix EUS Balloon
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
30d
Cleared
Apr 19, 2018
Embozene Color-Advanced Microspheres
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
93d
Cleared
Apr 19, 2018
Balloon Catheter and Balloon Ureteral Dilator Set
EZN
Dilator, Catheter, Ureteral
233d
Cleared
Apr 17, 2018
DiLumen C2
FDF
Colonoscope And Accessories, Flexible/rigid
180d
Cleared
Apr 17, 2018
Fusion OMNI Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
260d
Cleared
Apr 16, 2018
SOZO
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
90d
Cleared
Apr 16, 2018
Hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
217d
Cleared
Apr 16, 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
FAD
Stent, Ureteral
319d
Cleared
Apr 12, 2018
Padlock Clip defect closure device
PKL
Hemostatic Metal Clip For The Gi Tract
28d
Cleared
Apr 10, 2018
Imager II Urology Torque Catheter
KOD
Catheter, Urological
41d
Cleared
Apr 10, 2018
Eviva Stereotactic Guided Breast Biopsy System
KNW
Instrument, Biopsy
71d
Cleared
Apr 04, 2018
leva Pelvic Floor Trainer
HIR
Perineometer
23d
Cleared
Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
MSB
System And Accessories, Isolated Heart, Transport And Preservation
65d
Cleared
Mar 30, 2018
OLYMPUS URF-V2/V2R
FGB
Ureteroscope And Accessories, Flexible/rigid
247d
Cleared
Mar 30, 2018
Dimesol Tubing Sets for Hemodialysis
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
274d
Cleared
Mar 30, 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
PNR
Enteral Syringes With Enteral Specific Connectors
282d
Cleared
Mar 29, 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
EZL
Catheter, Retention Type, Balloon
134d
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