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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5373 Gastroenterology & Urology devices
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
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
FDI
Snare, Flexible
46d
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 20, 1997
ULTRAFLEX DIAMOND
FGE
Stents, Drains And Dilators For The Biliary Ducts
299d
Cleared
May 16, 1997
MANAN V.S. ACCESS NEEDLE/SET
FGE
Stents, Drains And Dilators For The Biliary Ducts
239d
Cleared
May 14, 1997
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
LIF
Dialyzer Reprocessing System
71d
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
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
EZB
Stylet For Catheter, Gastro-urology
10d
Cleared
May 02, 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
224d
Cleared
Apr 28, 1997
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
195d
Cleared
Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
KOB
Catheter, Suprapubic (and Accessories)
37d
Cleared
Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
85d
Cleared
Apr 17, 1997
VS-100 VIDEO SIGMOIDOSCOPE
FAM
Sigmoidoscope And Accessories, Flexible/rigid
73d
Cleared
Apr 15, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
56d
Cleared
Apr 11, 1997
MICROVASIVE GOLD PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
78d
Cleared
Apr 11, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
FCG
Biopsy Needle
57d
Cleared
Apr 03, 1997
12 URETEROSCOPES/URETERO-RENOSCOPES
FGB
Ureteroscope And Accessories, Flexible/rigid
190d
Cleared
Apr 02, 1997
STONE DISLODGER, BASKET
FGO
Dislodger, Stone, Flexible
78d
Cleared
Mar 28, 1997
ERCP CANNULA
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
234d
Cleared
Mar 28, 1997
ULTRATOMERX
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
80d
Cleared
Mar 25, 1997
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
222d
Cleared
Mar 25, 1997
EXTRACTORRX
FGE
Stents, Drains And Dilators For The Biliary Ducts
77d
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