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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8389 Gastroenterology & Urology devices
Cleared
Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
435d
Cleared
Dec 04, 2013
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
OCW
Endoscopic Tissue Approximation Device
139d
Cleared
Nov 26, 2013
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
FGB
Ureteroscope And Accessories, Flexible/rigid
197d
Cleared
Nov 26, 2013
CYBERWAND STERILE PROBE SET
FFK
Lithotriptor, Electro-hydraulic
81d
Cleared
Nov 25, 2013
INBODY
MNW
Analyzer, Body Composition
249d
Cleared
Nov 25, 2013
BIA / VITALITY ANALYZER
MNW
Analyzer, Body Composition
242d
Cleared
Nov 22, 2013
REDSENSE ALARM SYSTEM
ODX
Autonomous Extracorporeal Blood Leak Detector/alarm
263d
Cleared
Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
86d
Cleared
Nov 20, 2013
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
FCG
Biopsy Needle
56d
Cleared
Nov 15, 2013
AUTOLITH TOUCH
FFK
Lithotriptor, Electro-hydraulic
274d
Cleared
Nov 13, 2013
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
FIP
Subsystem, Water Purification
141d
Cleared
Nov 05, 2013
NURO NEUROMODULATION SYSTEM
NAM
Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
82d
Cleared
Nov 04, 2013
LIGHTHOUSE(TM) URINARY CATHETER
EZL
Catheter, Retention Type, Balloon
151d
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 22, 2013
RANFAC BONE MARROW ASPIRATION NEEDLE
KNW
Instrument, Biopsy
181d
Cleared
Oct 21, 2013
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
98d
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
Cleared
Oct 11, 2013
CLASSIC INTERMITTENT CATHETER
EZD
Catheter, Straight
51d
Cleared
Oct 10, 2013
PEERSCOPE SYSTEM
FDS
Gastroscope And Accessories, Flexible/rigid
147d
Cleared
Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
FKP
System, Dialysate Delivery, Single Patient
119d
Cleared
Oct 09, 2013
ESOPHAGEAL TTS STENT
ESW
Prosthesis, Esophageal
362d
Cleared
Oct 07, 2013
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
FGE
Stents, Drains And Dilators For The Biliary Ducts
161d
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