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
2656 Gastroenterology & Urology devices
Cleared
Oct 02, 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
51d
Cleared
Oct 02, 1996
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
FAS
Electrode, Electrosurgical, Active, Urological
406d
Cleared
Sep 17, 1996
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
GCM
Endoscope, Rigid
89d
Cleared
Sep 17, 1996
BRAUN HEMODIALYSIS CATHETER
MPB
Catheter, Hemodialysis, Non-implanted
463d
Cleared
Sep 13, 1996
MAHURKAR 8 FR DUAL LEMEN CATHETER
MPB
Catheter, Hemodialysis, Non-implanted
317d
Cleared
Sep 11, 1996
ENDOSCOPIC CLIP APPLIER
OCW
Endoscopic Tissue Approximation Device
77d
Cleared
Sep 04, 1996
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
FFS
Image, Illumination, Fiberoptic, For Endoscope
64d
Cleared
Sep 04, 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
KNT
Tubes, Gastrointestinal (and Accessories)
76d
Cleared
Aug 06, 1996
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
88d
Cleared
Aug 05, 1996
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
FHO
Pneumoperitoneum Needle
175d
Cleared
Jul 31, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
FFL
Dislodger, Stone, Basket, Ureteral, Metal
41d
Cleared
Jul 31, 1996
BALLON DILATATION CATHETER
KNQ
Dilator, Esophageal
107d
Cleared
Jul 30, 1996
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
KNW
Instrument, Biopsy
63d
Cleared
Jul 24, 1996
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
FEG
Tube, Double Lumen For Intestinal Decompression And/or Intubation
190d
Cleared
Jul 18, 1996
OLYMPUS BASKET GRASPERS (UROLOGY)
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
84d
Cleared
Jul 15, 1996
NEEDLE CATHETER
FBK
Endoscopic Injection Needle, Gastroenterology-urology
63d
Cleared
May 28, 1996
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
FFL
Dislodger, Stone, Basket, Ureteral, Metal
57d
Cleared
May 15, 1996
INJECTION GOLD PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
37d
Cleared
May 14, 1996
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
LJH
System, Irrigation, Urological
78d
Cleared
May 13, 1996
KANGAROO JEJUNAL FEEDING SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
87d
Cleared
May 09, 1996
KANGAROO FEEDING TUBE PLACMENT STYLET
KNT
Tubes, Gastrointestinal (and Accessories)
85d
Cleared
May 08, 1996
CORDIS BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
142d
Cleared
May 01, 1996
KARL STORZ URETER RESECTOSCOPE
FJL
Resectoscope
68d
Cleared
Apr 30, 1996
OLYMPUS KD SERIES SPHINCTEROTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
167d
Cleared
Apr 30, 1996
BRAUN HEMODIALYSIS BLOOD CIRCUITS
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
327d
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