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
5373 Gastroenterology & Urology devices
Cleared
Jun 04, 1999
STRYKER INFRAVISION ESOPHAGEAL KIT
FAT
Bougie, Esophageal, And Gastrointestinal, Gastro-urology
263d
Cleared
Jun 04, 1999
AUTO SUTURE ABBI SYSTEM
KNW
Instrument, Biopsy
256d
Cleared
Jun 01, 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
78d
Cleared
May 26, 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
MPB
Catheter, Hemodialysis, Non-implanted
30d
Cleared
May 20, 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
66d
Cleared
May 18, 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
MPB
Catheter, Hemodialysis, Non-implanted
187d
Cleared
May 05, 1999
CYSTIC DUCT BALLOON DILATING CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
238d
Cleared
Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
MQS
System, Hemodialysis, Access Recirculation Monitoring
158d
Cleared
Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
FGE
Stents, Drains And Dilators For The Biliary Ducts
63d
Cleared
Apr 30, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
FGE
Stents, Drains And Dilators For The Biliary Ducts
32d
Cleared
Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
KNY
Accessories, Catheter, G-u
22d
Cleared
Apr 21, 1999
SERIM BLOOD LEAK TEST STRIP
FJD
Detector, Leak, Blood
90d
Cleared
Apr 21, 1999
URETERAL ACCESS SHEATH SET
FED
Endoscopic Access Overtube, Gastroenterology-urology
43d
Cleared
Apr 15, 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
MPB
Catheter, Hemodialysis, Non-implanted
519d
Cleared
Mar 30, 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
15d
Cleared
Mar 26, 1999
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
FGB
Ureteroscope And Accessories, Flexible/rigid
78d
Cleared
Mar 25, 1999
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
EZN
Dilator, Catheter, Ureteral
73d
Cleared
Mar 25, 1999
WILSON-COOK BIPOLAR PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
65d
Cleared
Mar 25, 1999
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
41d
Cleared
Mar 22, 1999
KSEA ENDOSCOPE HOLDER
OCV
Endoscope Holder
47d
Cleared
Mar 08, 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
FIP
Subsystem, Water Purification
181d
Cleared
Mar 05, 1999
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
FBP
Telescope, Rigid, Endoscopic
67d
Cleared
Mar 03, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
FGE
Stents, Drains And Dilators For The Biliary Ducts
182d
Cleared
Feb 26, 1999
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
MSD
Catheter, Hemodialysis, Implanted
336d
Cleared
Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
MSD
Catheter, Hemodialysis, Implanted
225d
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