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
5367 Gastroenterology & Urology devices
Cleared
Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
EYB
Catheter, Ureteral, Gastro-urology
30d
Cleared
Jan 08, 2014
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
30d
Cleared
Jan 07, 2014
ENDOSCOPIC SUTURE CUTTER
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
29d
Cleared
Jan 06, 2014
OPTIFLUX ULTRA DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
445d
Cleared
Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
67d
Cleared
Jan 02, 2014
GELPOINT PATH TRANSANAL ACCESS PLATFORM
FER
Anoscope And Accessories
58d
Cleared
Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
FBO
Cystourethroscope
234d
Cleared
Dec 31, 2013
REPROCESSED DILATING TIP TROCARS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
131d
Cleared
Dec 27, 2013
NXSTAGE 1.6M2 DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
256d
Cleared
Dec 20, 2013
MULTI-STAGE SNARE
FDI
Snare, Flexible
38d
Cleared
Dec 20, 2013
SEAL BIOPSY VALVE - REUSABLE
OCX
Endoscopic Irrigation/suction System
106d
Cleared
Dec 20, 2013
IMAGE1 SPIES
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
176d
Cleared
Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
176d
Cleared
Dec 19, 2013
ELISIO-H HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
219d
Cleared
Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
FEQ
Pump, Air, Non-manual, For Endoscope
144d
Cleared
Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
338d
Cleared
Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
435d
Cleared
Nov 26, 2013
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
FGB
Ureteroscope And Accessories, Flexible/rigid
197d
Cleared
Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
86d
Cleared
Nov 15, 2013
AUTOLITH TOUCH
FFK
Lithotriptor, Electro-hydraulic
274d
Cleared
Nov 04, 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
FDI
Snare, Flexible
146d
Cleared
Oct 25, 2013
INSTINCT ENDOSCOPIC HEMOCLIP
PKL
Hemostatic Metal Clip For The Gi Tract
46d
Cleared
Oct 23, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
FPD
Tube, Feeding
145d
Cleared
Oct 15, 2013
ENDOCHOICE HOT BIOPSY FORCEPS
KGE
Forceps, Biopsy, Electric
109d
Cleared
Oct 11, 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
107d
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