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
Apr 26, 2022
SpeedCath Compact Male
EZD
Catheter, Straight
452d
Cleared
Apr 22, 2022
Avanos* CORTRAK* 2 Enteral Access System (EAS)
KNT
Tubes, Gastrointestinal (and Accessories)
52d
Cleared
Apr 15, 2022
Lilliput APD System
FKX
System, Peritoneal, Automatic Delivery
247d
Cleared
Apr 13, 2022
Keffort (MC-100, MC-100A)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
198d
Cleared
Apr 13, 2022
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
FAJ
Cystoscope And Accessories, Flexible/rigid
273d
Cleared
Apr 13, 2022
BIOTEQ Drainage Catheter BT-PDS-series
FGE
Stents, Drains And Dilators For The Biliary Ducts
426d
Cleared
Apr 11, 2022
G-EYE System
FDF
Colonoscope And Accessories, Flexible/rigid
82d
Cleared
Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
FIE
Needle, Fistula
200d
Cleared
Apr 06, 2022
Balloon Dilatation Catheter
FDF
Colonoscope And Accessories, Flexible/rigid
147d
Cleared
Apr 01, 2022
PuraStat-RM
PHN
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
144d
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
Apr 01, 2022
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
FDF
Colonoscope And Accessories, Flexible/rigid
448d
Cleared
Mar 29, 2022
Guidewire Locking Device
ODC
Endoscope Channel Accessory
60d
Cleared
Mar 21, 2022
Multi-Functional Electrosurgical Knife
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
182d
Cleared
Mar 18, 2022
15L Cycler Drainage Bag
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
86d
Cleared
Mar 17, 2022
RELIEF Ureteral Stent Kit
FAD
Stent, Ureteral
143d
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
Mar 08, 2022
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
EZD
Catheter, Straight
449d
Cleared
Mar 03, 2022
Hemoclip
PKL
Hemostatic Metal Clip For The Gi Tract
267d
Cleared
Mar 02, 2022
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
FAS
Electrode, Electrosurgical, Active, Urological
156d
Cleared
Mar 02, 2022
Bio Fluff System
KPL
Colonic Irrigation System
604d
Cleared
Feb 28, 2022
ENFit enteral syringes (NUTRIFIT)
PNR
Enteral Syringes With Enteral Specific Connectors
272d
Cleared
Feb 23, 2022
Sclerotherapy Needle
FBK
Endoscopic Injection Needle, Gastroenterology-urology
184d
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