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
5364 Gastroenterology & Urology devices
Cleared
May 21, 2020
LotusCatheter (Lotus No Balloon Catheter)
GBM
Catheter, Urethral
349d
Cleared
May 20, 2020
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
ESW
Prosthesis, Esophageal
49d
Cleared
May 15, 2020
AquaPulse Auxiliary Water Connector
OCX
Endoscopic Irrigation/suction System
78d
Cleared
May 14, 2020
Single Use Endoscope Valves Set
ODC
Endoscope Channel Accessory
288d
Cleared
May 08, 2020
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
268d
Cleared
May 07, 2020
Actreen Hi-Lite Intermittent Urinary Catheters
GBM
Catheter, Urethral
231d
Cleared
May 05, 2020
InMode System with vTone Applicator
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
90d
Cleared
May 01, 2020
Stone Retrieval Balloon
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
99d
Cleared
May 01, 2020
FUJIFILM EP-6000 Video Processor
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
253d
Not Cleared
Apr 29, 2020
CARPEDIEM System
QIR
Pediatric Hemodialysis System
568d
Cleared
Apr 28, 2020
Single Use Injector
FBK
Endoscopic Injection Needle, Gastroenterology-urology
230d
Cleared
Apr 24, 2020
Custodiol HTK Solution
KDL
Set, Perfusion, Kidney, Disposable
233d
Cleared
Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
270d
Cleared
Apr 23, 2020
Duo-Flow Side x Side Double Lumen Catheter
MPB
Catheter, Hemodialysis, Non-implanted
205d
Cleared
Apr 23, 2020
RocaTub Ureteral Catheter
EYB
Catheter, Ureteral, Gastro-urology
255d
Cleared
Apr 21, 2020
Lariat, Hot/Cold Snare
FDI
Snare, Flexible
29d
Cleared
Apr 21, 2020
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
EZL
Catheter, Retention Type, Balloon
266d
Cleared
Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
MQR
Stent, Colonic, Metallic, Expandable
74d
Cleared
Apr 16, 2020
EON Portable RO Water Purification System
FIP
Subsystem, Water Purification
34d
Cleared
Apr 15, 2020
G-EYE System
FDF
Colonoscope And Accessories, Flexible/rigid
209d
Cleared
Apr 14, 2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
OCX
Endoscopic Irrigation/suction System
56d
Cleared
Apr 08, 2020
Standard Bougie
KNT
Tubes, Gastrointestinal (and Accessories)
268d
Cleared
Apr 06, 2020
Irrigation Tubing with CO2 or Air
OCX
Endoscopic Irrigation/suction System
133d
Cleared
Apr 02, 2020
Ambu aScope 4 Cysto
FAJ
Cystoscope And Accessories, Flexible/rigid
147d
Cleared
Mar 31, 2020
Tablo Hemodialysis System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
8d
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