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
5369 Gastroenterology & Urology devices
Cleared
Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
MNW
Analyzer, Body Composition
111d
Cleared
Oct 20, 2006
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
KNW
Instrument, Biopsy
29d
Cleared
Oct 19, 2006
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
90d
Cleared
Oct 18, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
30d
Cleared
Oct 13, 2006
COLOPLAST OSTOMY ROD, MODEL 12814
EZP
Rod, Colostomy
423d
Cleared
Oct 02, 2006
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
OCW
Endoscopic Tissue Approximation Device
60d
Cleared
Sep 28, 2006
STRYKER URETERAL ILLUMINATION SYSTEM IV
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
115d
Cleared
Sep 25, 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
OCW
Endoscopic Tissue Approximation Device
94d
Cleared
Sep 22, 2006
EVIS EXERA II 180 SYSTEM
NWB
Endoscope, Accessories, Narrow Band Spectrum
64d
Cleared
Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
KNQ
Dilator, Esophageal
87d
Cleared
Sep 15, 2006
NUTRISAFE 2
FPD
Tube, Feeding
162d
Cleared
Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
74d
Cleared
Sep 11, 2006
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
KNT
Tubes, Gastrointestinal (and Accessories)
110d
Cleared
Sep 11, 2006
RENALSOFT
KPF
System, Dialysate Delivery, Semi-automatic, Peritoneal
102d
Cleared
Sep 06, 2006
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
FER
Anoscope And Accessories
182d
Cleared
Sep 05, 2006
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
169d
Cleared
Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
122d
Cleared
Aug 31, 2006
PRIMUS GPS BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
86d
Cleared
Aug 18, 2006
FOLEY CATHETERS WITH TEMPERATURE PROBE
EYC
Catheter, Upper Urinary Tract
43d
Cleared
Aug 04, 2006
MARATHON STENT WITH FUSION TECHNOLOGY
FGE
Stents, Drains And Dilators For The Biliary Ducts
149d
Cleared
Jul 31, 2006
NXSTAGE CARTRIDGE EXPRESS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
32d
Cleared
Jul 03, 2006
I-STYLE BONE MARROW ASPIRATION NEEDLE
KNW
Instrument, Biopsy
27d
Cleared
Jun 27, 2006
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
FBO
Cystourethroscope
15d
Cleared
Jun 05, 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
33d
Cleared
May 30, 2006
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
FCK
Instrument, Biopsy, Suction
29d
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