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
8428 Gastroenterology & Urology devices
Cleared
Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
KOD
Catheter, Urological
74d
Cleared
Sep 06, 2002
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
OCW
Endoscopic Tissue Approximation Device
58d
Cleared
Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
KNT
Tubes, Gastrointestinal (and Accessories)
27d
Cleared
Sep 03, 2002
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
EZL
Catheter, Retention Type, Balloon
743d
Cleared
Sep 03, 2002
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
FCG
Biopsy Needle
90d
Cleared
Aug 30, 2002
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
KNT
Tubes, Gastrointestinal (and Accessories)
113d
Cleared
Aug 30, 2002
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
FAS
Electrode, Electrosurgical, Active, Urological
29d
Cleared
Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
MSD
Catheter, Hemodialysis, Implanted
90d
Cleared
Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
21d
Cleared
Aug 22, 2002
NANMA ADJUSTABLE CONSTRICTION RING
LKY
Device, External Penile Rigidity
345d
Cleared
Aug 20, 2002
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
GCT
Light Source, Endoscope, Xenon Arc
89d
Cleared
Aug 16, 2002
MODULITH SLK LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
441d
Cleared
Aug 15, 2002
KSEA QUADRO SWITCH
OCX
Endoscopic Irrigation/suction System
78d
Cleared
Aug 14, 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
KNW
Instrument, Biopsy
83d
Cleared
Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
65d
Cleared
Aug 12, 2002
TRANSONIC FLOW-QC SET MODEL ADT1010
MQS
System, Hemodialysis, Access Recirculation Monitoring
90d
Cleared
Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
18d
Cleared
Aug 08, 2002
URETERAL STENT
FAD
Stent, Ureteral
267d
Cleared
Aug 06, 2002
PRISMA SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
508d
Cleared
Aug 05, 2002
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
FIP
Subsystem, Water Purification
787d
Cleared
Aug 05, 2002
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
270d
Cleared
Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
MND
Ligator, Esophageal
11d
Cleared
Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
KNT
Tubes, Gastrointestinal (and Accessories)
200d
Cleared
Aug 01, 2002
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
94d
Cleared
Jul 29, 2002
REPROCESSED TROCARS AND CANNULAS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
350d
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