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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8424 Gastroenterology & Urology devices
Cleared
Jul 09, 2003
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
FGE
Stents, Drains And Dilators For The Biliary Ducts
131d
Cleared
Jul 08, 2003
NGT
KNT
Tubes, Gastrointestinal (and Accessories)
340d
Cleared
Jul 07, 2003
NXSTAGE SYSTEM ONE
FII
System, Dialysate Delivery, Sealed
145d
Cleared
Jul 07, 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Jul 03, 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
191d
Cleared
Jul 03, 2003
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
NLR
Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed
101d
Cleared
Jul 01, 2003
GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
91d
Cleared
Jun 30, 2003
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
ESW
Prosthesis, Esophageal
129d
Cleared
Jun 30, 2003
ASAP CYSTOSCOPE
FAJ
Cystoscope And Accessories, Flexible/rigid
81d
Cleared
Jun 27, 2003
ETI BIPOLAR HEMOSTATIC PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
88d
Cleared
Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
42d
Cleared
Jun 26, 2003
OSMONICS SOLUTION DELIVERY SYSTEM
FIN
Tank, Holding, Dialysis
290d
Cleared
Jun 25, 2003
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
MNW
Analyzer, Body Composition
222d
Cleared
Jun 24, 2003
ENDO GATOR SYSTEM
OCX
Endoscopic Irrigation/suction System
15d
Cleared
Jun 19, 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
FAS
Electrode, Electrosurgical, Active, Urological
79d
Cleared
Jun 18, 2003
GYNE IDEAS MINITAPE RP DEVICE
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
208d
Cleared
Jun 17, 2003
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
229d
Cleared
Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
158d
Cleared
Jun 17, 2003
URINARY CATHETERS
GBM
Catheter, Urethral
43d
Cleared
Jun 16, 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
164d
Cleared
Jun 16, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
61d
Cleared
Jun 11, 2003
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
189d
Cleared
Jun 09, 2003
HOBBS MISTIFIER SPRAY CATHETER
OCX
Endoscopic Irrigation/suction System
90d
Cleared
Jun 05, 2003
MODIFICATION TO CAVERMAP SURGICAL AID
FGM
Probe And Director, Gastro-urology
21d
Cleared
Jun 03, 2003
SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
OCU
Endoscopic Storage Cover
90d
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