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
2287 Gastroenterology & Urology devices
Cleared
Dec 06, 2021
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
90d
Cleared
Dec 03, 2021
Everyway Incontinence Stimulation System
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
67d
Cleared
Dec 01, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
247d
Cleared
Nov 26, 2021
Tablo Cartridge
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
255d
Cleared
Nov 24, 2021
Regulora
QMY
Computerized Behavioral Therapy Device For Treating Symptoms
197d
Cleared
Nov 23, 2021
Exablate Prostate System
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
137d
Cleared
Nov 23, 2021
Uretero1 Ureteroscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
204d
Not Cleared
Nov 23, 2021
vPatch
QRC
Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation
238d
Cleared
Nov 22, 2021
Agile Esophageal OTW Stent System
ESW
Prosthesis, Esophageal
151d
Cleared
Nov 19, 2021
EndoScreener
QNP
Gastrointesinal Lesion Software Detection System
203d
Cleared
Nov 19, 2021
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
KOD
Catheter, Urological
226d
Cleared
Nov 18, 2021
HANAROSTENT Esophagus Asymmetric (CCC)
ESW
Prosthesis, Esophageal
49d
Cleared
Nov 17, 2021
Qora Stool Management Kit
KNT
Tubes, Gastrointestinal (and Accessories)
104d
Cleared
Nov 16, 2021
Enteral Feeding Set
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
238d
Cleared
Nov 10, 2021
Disposable Automatic Core Biopsy Instrument
KNW
Instrument, Biopsy
112d
Cleared
Nov 10, 2021
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
138d
Cleared
Nov 03, 2021
FLUME catheter
EZL
Catheter, Retention Type, Balloon
117d
Cleared
Nov 02, 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
246d
Cleared
Oct 29, 2021
Balloon BS-3
FDA
Enteroscope And Accessories
30d
Cleared
Oct 22, 2021
DiLumen C2 and Tool Mount
FDF
Colonoscope And Accessories, Flexible/rigid
133d
Cleared
Oct 20, 2021
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
OCX
Endoscopic Irrigation/suction System
233d
Cleared
Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
FDS
Gastroscope And Accessories, Flexible/rigid
271d
Cleared
Oct 19, 2021
U9000 Plus Ultrafilter
FIP
Subsystem, Water Purification
195d
Cleared
Oct 15, 2021
RM4 Control Unit
KDN
System, Perfusion, Kidney
175d
Cleared
Oct 08, 2021
Esophageal TTS Stent
ESW
Prosthesis, Esophageal
127d
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