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
2657 Gastroenterology & Urology devices
Cleared
Apr 17, 1987
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
57d
Cleared
Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
24d
Cleared
Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
24d
Cleared
Apr 06, 1987
CAPILLARY FLOW DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
82d
Cleared
Apr 01, 1987
SOFT TISSUE BIOPSY NEEDLE
KNW
Instrument, Biopsy
34d
Cleared
Mar 10, 1987
EXTERNAL Y VALVE 5C4198
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
56d
Cleared
Feb 25, 1987
ACUTE PERITONEAL DIALYSIS KIT
FKO
Catheter, Peritoneal Dialysis, Single Use
22d
Cleared
Feb 18, 1987
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
LFK
Catheter, Femoral
50d
Cleared
Dec 16, 1986
MODIFIED DUAL LUMEN NEEDLE
LBW
Set, Dialysis, Single Needle (co-axial Flow)
21d
Cleared
Oct 29, 1986
BARD BALLOON DILATATION SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
54d
Cleared
Oct 24, 1986
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
FAE
Prosthesis, Penile
8d
Cleared
Oct 16, 1986
BARD IRYFIX(TM) STOMA CAP
EXB
Collector, Ostomy
98d
Cleared
Oct 02, 1986
DISPOSABLE PNEUMOPERITONEUM NEEDLE
FHO
Pneumoperitoneum Needle
44d
Cleared
Oct 02, 1986
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
LFJ
Catheter, Subclavian
10d
Cleared
Jul 15, 1986
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
KNT
Tubes, Gastrointestinal (and Accessories)
77d
Cleared
Jun 19, 1986
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
42d
Cleared
May 15, 1986
BARD DOUBLE PIGTAIL URETERAL STENT
FAD
Stent, Ureteral
23d
Cleared
Apr 29, 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
89d
Cleared
Apr 23, 1986
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
LFJ
Catheter, Subclavian
29d
Cleared
Apr 07, 1986
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
41d
Cleared
Mar 04, 1986
DUAL LUMEN NEEDLE (PRODUCT CHANGE)
LBW
Set, Dialysis, Single Needle (co-axial Flow)
21d
Cleared
Feb 10, 1986
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
KNW
Instrument, Biopsy
59d
Cleared
Feb 05, 1986
CAPD TRANSFER SET SPIKE 5C4363
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
14d
Cleared
Jan 23, 1986
DYNAFEED ENTERAL PUMP FEED BAG
KNT
Tubes, Gastrointestinal (and Accessories)
16d
Cleared
Jan 21, 1986
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
148d
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