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
5362 Gastroenterology & Urology devices
Cleared
Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
ODC
Endoscope Channel Accessory
169d
Cleared
Jan 13, 2021
MyOnyx System
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
271d
Cleared
Jan 08, 2021
BioGuard Air/Water and Suction Valves
ODC
Endoscope Channel Accessory
28d
Cleared
Jan 06, 2021
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
ODC
Endoscope Channel Accessory
287d
Cleared
Jan 06, 2021
Applied Medical Anoscope
FER
Anoscope And Accessories
366d
Cleared
Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
68d
Cleared
Dec 30, 2020
Foley Balloon Catheter for Urology
EZL
Catheter, Retention Type, Balloon
184d
Cleared
Dec 28, 2020
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
80d
Cleared
Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
MPB
Catheter, Hemodialysis, Non-implanted
307d
Cleared
Dec 23, 2020
Locking device
ODC
Endoscope Channel Accessory
138d
Cleared
Dec 23, 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
358d
Not Cleared
Dec 23, 2020
EndoRotor Device
QNE
Endoscopic Pancreatic Debridement Device
282d
Cleared
Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
FGE
Stents, Drains And Dilators For The Biliary Ducts
56d
Cleared
Dec 17, 2020
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
LJE
Catheter, Nephrostomy
230d
Cleared
Dec 16, 2020
Disposable Stone Extraction basket
LQR
Dislodger, Stone, Biliary
194d
Cleared
Dec 15, 2020
Prefilled Syringe
EZL
Catheter, Retention Type, Balloon
90d
Cleared
Dec 15, 2020
X-Tack Endoscopic HeliX Tacking System
PKL
Hemostatic Metal Clip For The Gi Tract
167d
Cleared
Dec 10, 2020
AquaPulse Irrigation Tubing
OCX
Endoscopic Irrigation/suction System
97d
Cleared
Dec 09, 2020
Cystoject Syringe Lever
QBL
Piston Syringe Lever
27d
Cleared
Dec 09, 2020
ClearPetra Suction-Evacuation Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
54d
Cleared
Dec 04, 2020
TubeClear System
KNT
Tubes, Gastrointestinal (and Accessories)
267d
Cleared
Dec 03, 2020
ORISE ProKnife
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
288d
Cleared
Nov 25, 2020
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
377d
Not Cleared
Nov 25, 2020
Parallel
QMY
Computerized Behavioral Therapy Device For Treating Symptoms
209d
Cleared
Nov 20, 2020
Dornier MAGELLAN Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
142d
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