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
5372 Gastroenterology & Urology devices
Cleared
Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
161d
Cleared
Oct 25, 2002
COOK INJECTION NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
88d
Cleared
Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Oct 21, 2002
NXSTAGE PREMIXED DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
48d
Cleared
Oct 17, 2002
WILSON-COOK CYSTOTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
73d
Cleared
Oct 11, 2002
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL
MSD
Catheter, Hemodialysis, Implanted
203d
Cleared
Sep 27, 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
158d
Cleared
Sep 18, 2002
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
ODA
Endoscopic Central Control Unit
237d
Cleared
Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
KOD
Catheter, Urological
74d
Cleared
Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
KNT
Tubes, Gastrointestinal (and Accessories)
27d
Cleared
Sep 03, 2002
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
EZL
Catheter, Retention Type, Balloon
743d
Cleared
Aug 30, 2002
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
FAS
Electrode, Electrosurgical, Active, Urological
29d
Cleared
Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
MSD
Catheter, Hemodialysis, Implanted
90d
Cleared
Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
21d
Cleared
Aug 16, 2002
MODULITH SLK LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
441d
Cleared
Aug 15, 2002
KSEA QUADRO SWITCH
OCX
Endoscopic Irrigation/suction System
78d
Cleared
Aug 14, 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
KNW
Instrument, Biopsy
83d
Cleared
Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
65d
Cleared
Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
18d
Cleared
Aug 08, 2002
URETERAL STENT
FAD
Stent, Ureteral
267d
Cleared
Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
MND
Ligator, Esophageal
11d
Cleared
Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
KNT
Tubes, Gastrointestinal (and Accessories)
200d
Cleared
Jul 19, 2002
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
ESW
Prosthesis, Esophageal
421d
Cleared
Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
190d
Cleared
Jul 02, 2002
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
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