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
8434 Gastroenterology & Urology devices
Cleared
Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
KNW
Instrument, Biopsy
23d
Cleared
Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
FIE
Needle, Fistula
74d
Cleared
Nov 16, 2000
ADVANCED UROSCIENCE INNERSHEATH
FBK
Endoscopic Injection Needle, Gastroenterology-urology
90d
Cleared
Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
MSE
Hemodialyzer, Re-use, Low Flux
167d
Cleared
Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
OCW
Endoscopic Tissue Approximation Device
88d
Cleared
Nov 01, 2000
MEDOVATIONS ESOPHAGEAL DILATOR
KNQ
Dilator, Esophageal
90d
Cleared
Oct 31, 2000
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
KNW
Instrument, Biopsy
75d
Cleared
Oct 30, 2000
NIR BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
108d
Cleared
Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
MSF
Hemodialyzer, Re-use, High Flux
303d
Cleared
Oct 25, 2000
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
FIP
Subsystem, Water Purification
132d
Cleared
Oct 25, 2000
ACCESS ALERT GAUGE
KOC
Accessories, Blood Circuit, Hemodialysis
82d
Cleared
Oct 19, 2000
IMPOAID
LKY
Device, External Penile Rigidity
227d
Cleared
Oct 13, 2000
ENDOCARE PERCUTANEOUS ACCESS SET
KOD
Catheter, Urological
67d
Cleared
Oct 12, 2000
NIR BILLIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
87d
Cleared
Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
ESW
Prosthesis, Esophageal
87d
Cleared
Oct 05, 2000
RAPID EXCHANGE TAPERTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
27d
Cleared
Sep 29, 2000
BRAVO PH MONITORING SYSTEM
FFT
Electrode, Ph, Stomach
88d
Cleared
Sep 25, 2000
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH
MPB
Catheter, Hemodialysis, Non-implanted
90d
Cleared
Sep 14, 2000
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
MPB
Catheter, Hemodialysis, Non-implanted
301d
Cleared
Sep 08, 2000
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
FDS
Gastroscope And Accessories, Flexible/rigid
88d
Cleared
Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
216d
Cleared
Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
125d
Cleared
Aug 29, 2000
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
68d
Cleared
Aug 28, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices