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
617 Gastroenterology & Urology devices
Cleared
Aug 04, 2022
MANTIS Clip
PKL
Hemostatic Metal Clip For The Gi Tract
108d
Cleared
Jul 27, 2022
Dornier Thulio
GEX
Powered Laser Surgical Instrument
300d
Cleared
Jun 13, 2022
Disposable Hemostatic Closure Clip Device
PKL
Hemostatic Metal Clip For The Gi Tract
145d
Not Cleared
Jun 13, 2022
ProdiGI
QSW
Endoscopic Traction Device
150d
Cleared
Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
FAD
Stent, Ureteral
252d
Cleared
May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
233d
Cleared
May 13, 2022
Telepack +
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
18d
Cleared
May 12, 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
267d
Cleared
May 11, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
FDT
Duodenoscope And Accessories, Flexible/rigid
71d
Cleared
May 09, 2022
Compass BDS Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
143d
Cleared
May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
263d
Cleared
May 06, 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
FGE
Stents, Drains And Dilators For The Biliary Ducts
396d
Cleared
Apr 15, 2022
Lilliput APD System
FKX
System, Peritoneal, Automatic Delivery
247d
Cleared
Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
259d
Cleared
Apr 01, 2022
HD-550 Video Endoscope System
NWB
Endoscope, Accessories, Narrow Band Spectrum
284d
Cleared
Mar 29, 2022
Guidewire Locking Device
ODC
Endoscope Channel Accessory
60d
Cleared
Mar 18, 2022
15L Cycler Drainage Bag
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
86d
Cleared
Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
FEQ
Pump, Air, Non-manual, For Endoscope
28d
Cleared
Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
LJE
Catheter, Nephrostomy
262d
Cleared
Feb 17, 2022
LoFric Elle
EZD
Catheter, Straight
300d
Cleared
Feb 16, 2022
NovoFlow Reinforced Ureteral Stent
FAD
Stent, Ureteral
140d
Cleared
Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
KGE
Forceps, Biopsy, Electric
29d
Cleared
Feb 03, 2022
Ambu® aScope™ Gastro, Ambu® aBox™2
FDS
Gastroscope And Accessories, Flexible/rigid
185d
Cleared
Jan 24, 2022
Revaclear 500, Revaclear 400, Revaclear 300
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
67d
Cleared
Jan 20, 2022
Entuit PEG, Entuit PEGJ
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
100d
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