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
Jul 16, 2019
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
LJE
Catheter, Nephrostomy
256d
Cleared
Jul 11, 2019
EndoStream(TM)
OCX
Endoscopic Irrigation/suction System
402d
Cleared
Jul 11, 2019
ScopeFlow Pure(TM)
OCX
Endoscopic Irrigation/suction System
406d
Cleared
Jul 10, 2019
SpeediCath Flex Coude Pro
GBM
Catheter, Urethral
121d
Cleared
Jul 02, 2019
Uro-N Cystoscope
FAJ
Cystoscope And Accessories, Flexible/rigid
263d
Cleared
Jun 28, 2019
ClearEndoclip
PKL
Hemostatic Metal Clip For The Gi Tract
239d
Cleared
Jun 27, 2019
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
OCX
Endoscopic Irrigation/suction System
28d
Cleared
Jun 26, 2019
Deflectable Brush Biopsy Set
FDX
Endoscopic Cytology Brush
22d
Cleared
Jun 26, 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
KGC
Tube, Gastro-enterostomy
260d
Cleared
Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
FDA
Enteroscope And Accessories
235d
Cleared
Jun 21, 2019
Aqua Medical RF Vapor System
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
182d
Cleared
Jun 21, 2019
EsoCheck CCD Cell Collection Device
EOX
Esophagoscope (flexible Or Rigid)
210d
Cleared
Jun 17, 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
EYB
Catheter, Ureteral, Gastro-urology
263d
Cleared
Jun 14, 2019
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
KNT
Tubes, Gastrointestinal (and Accessories)
21d
Cleared
Jun 14, 2019
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
113d
Cleared
Jun 14, 2019
Trio-CT Triple Lumen Catheter
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
206d
Cleared
Jun 13, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
FJL
Resectoscope
24d
Cleared
Jun 13, 2019
Strome-Blitzer Cytology Balloon
EOX
Esophagoscope (flexible Or Rigid)
308d
Cleared
Jun 12, 2019
Medline Poly-Cath Red Polymer Urethral Catheter
GBM
Catheter, Urethral
191d
Cleared
Jun 07, 2019
Andorate Auxiliary Water Connector, Andorate Valves Set
ODC
Endoscope Channel Accessory
30d
Cleared
Jun 06, 2019
Pure Vu System
FDF
Colonoscope And Accessories, Flexible/rigid
30d
Cleared
Jun 04, 2019
CORTRAK* 2 Equilateral Enteral Access System
KNT
Tubes, Gastrointestinal (and Accessories)
15d
Cleared
May 31, 2019
U Deliver Bolink ENFit Enteral Feeding Sets
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
108d
Cleared
May 31, 2019
Pristine Hemodialysis Catheter
MSD
Catheter, Hemodialysis, Implanted
266d
Cleared
May 30, 2019
Arc Endocuff Glide AEG110 & AEG120
FED
Endoscopic Access Overtube, Gastroenterology-urology
38d
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