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
9843
Total
9796
Cleared
154d
Avg (2y)
1976
Since
2655 Gastroenterology & Urology devices
Cleared
Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
83d
Cleared
Sep 15, 1997
AUXILIARY INSTRUMENTS FOR URS
FCL
Forceps, Biopsy, Non-electric
159d
Cleared
Sep 09, 1997
BLOOD MONITOR PUMP
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
203d
Cleared
Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
FPD
Tube, Feeding
89d
Cleared
Aug 15, 1997
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
OCY
Endoscopic Guidewire, Gastroenterology-urology
80d
Cleared
Aug 12, 1997
KARL STORZ MODEL 203020 20 EQUIMAT
LJH
System, Irrigation, Urological
75d
Cleared
Aug 12, 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
75d
Cleared
Jul 24, 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
115d
Cleared
Jul 16, 1997
OLYMPUS OES OTV-S5C VIDEO SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
91d
Cleared
Jul 14, 1997
MRI NEEDLES
FCG
Biopsy Needle
312d
Cleared
Jul 01, 1997
OLYMPUS CD-6C-1 COAGULATION ELECTRODE
FFE
System, Water Jet Catheter, Renal
82d
Cleared
Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
189d
Cleared
Jun 27, 1997
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
PKL
Hemostatic Metal Clip For The Gi Tract
317d
Cleared
Jun 20, 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
210d
Cleared
Jun 11, 1997
ASPISAFE GASTRIC TUBE
BSS
Tube, Nasogastric
405d
Cleared
Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
LJH
System, Irrigation, Urological
88d
Cleared
May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
275d
Cleared
May 20, 1997
ULTRAFLEX DIAMOND
FGE
Stents, Drains And Dilators For The Biliary Ducts
299d
Cleared
May 05, 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
OCV
Endoscope Holder
486d
Cleared
May 02, 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
224d
Cleared
Apr 11, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
FCG
Biopsy Needle
57d
Cleared
Apr 11, 1997
MICROVASIVE GOLD PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
78d
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
ULTRATOMERX
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
80d
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