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
Jun 24, 2002
TANITA BODY COMPOSITION ANALYZER
MNW
Analyzer, Body Composition
201d
Cleared
Jun 21, 2002
HORIZONS HOT BIOPSY FORCEPS
KGE
Forceps, Biopsy, Electric
29d
Cleared
Jun 21, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jun 17, 2002
NAKAO SNARE II AND NAKAO SNARE III
FDI
Snare, Flexible
90d
Cleared
Jun 07, 2002
INSIGHT, MODEL S980000
FFX
System, Gastrointestinal Motility (electrical)
326d
Cleared
Jun 05, 2002
ENDOSCOPIC LIGHT SOURCE XL202/L3
GCT
Light Source, Endoscope, Xenon Arc
78d
Cleared
Jun 05, 2002
VACURECT VACUUM CONSTRICTION DEVICE
LKY
Device, External Penile Rigidity
71d
Cleared
Jun 03, 2002
SYSTEM 100
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
206d
Cleared
May 31, 2002
ENTERYX INJECTOR
FBK
Endoscopic Injection Needle, Gastroenterology-urology
204d
Cleared
May 30, 2002
SURX RF SYSTEM
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
66d
Cleared
May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
MSD
Catheter, Hemodialysis, Implanted
115d
Cleared
May 24, 2002
IRRIGATING CANNULA
OCX
Endoscopic Irrigation/suction System
88d
Cleared
May 22, 2002
MEDCOMP ASH SPLIT-CATH II
MSD
Catheter, Hemodialysis, Implanted
99d
Cleared
May 22, 2002
APPLIED URETERAL CATHETER
EYB
Catheter, Ureteral, Gastro-urology
90d
Cleared
May 22, 2002
HDM97
FIZ
Meter, Conductivity, Non-remote
63d
Cleared
May 22, 2002
HDM99
FIZ
Meter, Conductivity, Non-remote
63d
Cleared
May 20, 2002
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
KNW
Instrument, Biopsy
63d
Cleared
May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
MSD
Catheter, Hemodialysis, Implanted
30d
Cleared
May 15, 2002
HERNIAMESH T-SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
76d
Cleared
May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
23d
Cleared
May 09, 2002
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
LKY
Device, External Penile Rigidity
240d
Cleared
May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
NFK
Kit, Repair, Catheter, Hemodialysis
90d
Cleared
May 09, 2002
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
FDC
Resectoscope, Working Element
28d
Cleared
May 08, 2002
WILSON-COOK ZILVER BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
58d
Cleared
May 07, 2002
MAINSTREAM WATER PURIFICATION DEVICE
NHV
System, Water Purification, General Medical Use
265d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices