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
8448 Gastroenterology & Urology devices
Cleared
May 23, 1997
BETTER-BLADDER (BB)
FIB
Protector, Transducer, Dialysis
204d
Cleared
May 23, 1997
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
134d
Cleared
May 23, 1997
#ES-32 SUCTION CATHETER 32 FR.
KNT
Tubes, Gastrointestinal (and Accessories)
73d
Cleared
May 23, 1997
ENDO SMARTCAP (100501)
OCX
Endoscopic Irrigation/suction System
57d
Cleared
May 23, 1997
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
FDI
Snare, Flexible
46d
Cleared
May 23, 1997
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
OCV
Endoscope Holder
23d
Cleared
May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
275d
Cleared
May 21, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
163d
Cleared
May 21, 1997
TR NEEDLE
KNW
Instrument, Biopsy
72d
Cleared
May 21, 1997
PAN (CHIBA ASPIRATING NEEDLE)
KNW
Instrument, Biopsy
72d
Cleared
May 20, 1997
UROSTYM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
363d
Cleared
May 20, 1997
ULTRAFLEX DIAMOND
FGE
Stents, Drains And Dilators For The Biliary Ducts
299d
Cleared
May 20, 1997
VISTA SINGLE CHIP VIDEO CAMERA
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
36d
Cleared
May 20, 1997
CLARUS MODEL 5197 SIGHTLITE
FTI
Lamp, Endoscope, Incandescent
29d
Cleared
May 19, 1997
FREEDOM TRAVELLER
MLW
Warmer, Peritoneal Dialysate
168d
Cleared
May 16, 1997
MANAN V.S. ACCESS NEEDLE/SET
FGE
Stents, Drains And Dilators For The Biliary Ducts
239d
Cleared
May 16, 1997
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
EZL
Catheter, Retention Type, Balloon
78d
Cleared
May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
LIF
Dialyzer Reprocessing System
71d
Cleared
May 12, 1997
MEDISYSTEMS TRANDUCER PROTECTOR
FIB
Protector, Transducer, Dialysis
89d
Cleared
May 09, 1997
T-RX RETRIEVAL FORCEPS
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
52d
Cleared
May 08, 1997
VAPOR-TECH SLED ELECTRODE
FAS
Electrode, Electrosurgical, Active, Urological
70d
Cleared
May 07, 1997
ANGLED TIP POLYPECTOMY SNARE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
54d
Cleared
May 05, 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
OCV
Endoscope Holder
486d
Cleared
May 05, 1997
O'REGAN LIGATOR
FHN
Ligator, Hemorrhoidal
264d
Cleared
May 05, 1997
FIEGERT ENDOTECH CYSTOSCOPE
FAJ
Cystoscope And Accessories, Flexible/rigid
55d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices