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
2290 Gastroenterology & Urology devices
Cleared
May 29, 2019
Swiss LithoClast Trilogy
FFK
Lithotriptor, Electro-hydraulic
30d
Cleared
May 29, 2019
Entuit PEG, Entuit PEGJ
KNT
Tubes, Gastrointestinal (and Accessories)
177d
Cleared
May 29, 2019
Segmented Esophageal Stent System
ESW
Prosthesis, Esophageal
224d
Cleared
May 29, 2019
Peel-Away Introducer
FED
Endoscopic Access Overtube, Gastroenterology-urology
267d
Cleared
May 24, 2019
Tria Firm Ureteral Stent
FAD
Stent, Ureteral
77d
Cleared
May 24, 2019
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
KOD
Catheter, Urological
303d
Cleared
May 23, 2019
ERBEFLO 2 Disposable Tubing System
OCX
Endoscopic Irrigation/suction System
86d
Cleared
May 17, 2019
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
LJE
Catheter, Nephrostomy
197d
Cleared
May 15, 2019
Flexible Overtube
FED
Endoscopic Access Overtube, Gastroenterology-urology
244d
Cleared
May 15, 2019
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
253d
Cleared
May 14, 2019
BAROnova Insufflation System, BAROnova Accessory Kit
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
29d
Cleared
May 08, 2019
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
GBM
Catheter, Urethral
145d
Cleared
May 07, 2019
Scope ProTech
OCU
Endoscopic Storage Cover
21d
Cleared
May 07, 2019
FUJIFILM Endoscope Model EC-760S-V/L
FDF
Colonoscope And Accessories, Flexible/rigid
55d
Cleared
May 04, 2019
Medline Quick-Clear Wand
KNT
Tubes, Gastrointestinal (and Accessories)
134d
Cleared
May 03, 2019
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
FGB
Ureteroscope And Accessories, Flexible/rigid
165d
Cleared
May 01, 2019
Brush Biopsy Set
FDX
Endoscopic Cytology Brush
257d
Cleared
Apr 30, 2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
KNT
Tubes, Gastrointestinal (and Accessories)
96d
Cleared
Apr 30, 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
PNR
Enteral Syringes With Enteral Specific Connectors
131d
Cleared
Apr 29, 2019
Magnetic Surgical System
PNL
Magnetic Surgical System
117d
Cleared
Apr 25, 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
294d
Cleared
Apr 23, 2019
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
43d
Cleared
Apr 23, 2019
Flexible HD Cysto-Urethroscope System
FAJ
Cystoscope And Accessories, Flexible/rigid
207d
Cleared
Apr 23, 2019
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
FAD
Stent, Ureteral
273d
Cleared
Apr 19, 2019
CapsoCam Plus (SV-3)
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
151d
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