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
8420 Gastroenterology & Urology devices
Cleared
Jun 07, 2006
DUTECK BODY COMPOSITION ANALYZER
MNW
Analyzer, Body Composition
89d
Cleared
Jun 05, 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
33d
Cleared
May 31, 2006
ACCUTECH ENDOLITE PROBE
FFS
Image, Illumination, Fiberoptic, For Endoscope
48d
Cleared
May 30, 2006
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
FCK
Instrument, Biopsy, Suction
29d
Cleared
May 24, 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
155d
Cleared
May 24, 2006
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
FKT
System, Dialysate Delivery, Sorbent Regenerated
99d
Cleared
May 24, 2006
BC100 BODY COMPOSITION ANALYSIS SYSTEM
MNW
Analyzer, Body Composition
83d
Cleared
May 24, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
NSI
System, Imaging, Esophageal, Wireless, Capsule
61d
Cleared
May 23, 2006
REPROCESSED ENDOSCOPIC TROCAR
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
272d
Cleared
May 15, 2006
USGI TRANSPORT ENDOSCOPIC GUIDE
FED
Endoscopic Access Overtube, Gastroenterology-urology
13d
Cleared
May 14, 2006
CATHASSIST
KNY
Accessories, Catheter, G-u
206d
Cleared
May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
MQR
Stent, Colonic, Metallic, Expandable
92d
Cleared
May 09, 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
MSD
Catheter, Hemodialysis, Implanted
109d
Cleared
May 08, 2006
GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
129d
Cleared
May 02, 2006
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
EZN
Dilator, Catheter, Ureteral
20d
Cleared
Apr 28, 2006
ENTAKE STANDARD AND SAFETY PEG SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
15d
Cleared
Apr 27, 2006
INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
KNW
Instrument, Biopsy
70d
Cleared
Apr 27, 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Apr 26, 2006
PREFTEST PROFESSIONAL SUITE
LIL
Monitor, Penile Tumescence
189d
Cleared
Apr 24, 2006
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
89d
Cleared
Apr 21, 2006
OHMEGA
FFX
System, Gastrointestinal Motility (electrical)
88d
Cleared
Apr 19, 2006
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
OCX
Endoscopic Irrigation/suction System
12d
Cleared
Apr 13, 2006
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
MSD
Catheter, Hemodialysis, Implanted
111d
Cleared
Apr 12, 2006
OMNILINK .035 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
120d
Cleared
Apr 11, 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
KNQ
Dilator, Esophageal
64d
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