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
5367 Gastroenterology & Urology devices
Cleared
May 09, 2011
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
FDI
Snare, Flexible
151d
Cleared
May 06, 2011
ASPIRA PERITONEAL DRAINAGE SYSTEM
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
84d
Cleared
Apr 20, 2011
CRE BALLOON DILATATION CATHETER
FDT
Duodenoscope And Accessories, Flexible/rigid
26d
Cleared
Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
15d
Cleared
Apr 06, 2011
MULTIPLE BIOPSY SYSTEM
FCK
Instrument, Biopsy, Suction
145d
Cleared
Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
FKX
System, Peritoneal, Automatic Delivery
177d
Cleared
Mar 29, 2011
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
MUM
Stent, Metallic, Expandable, Duodenal
299d
Cleared
Mar 22, 2011
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
FEQ
Pump, Air, Non-manual, For Endoscope
95d
Cleared
Mar 07, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
307d
Cleared
Feb 24, 2011
SINGLE USE BILIARY DRAINAGE STENT V
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Feb 15, 2011
SYSTEMS INTEGRATION
ODA
Endoscopic Central Control Unit
144d
Cleared
Feb 03, 2011
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
ONW
Hemodialysis System For Home Use
1491d
Cleared
Feb 01, 2011
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
176d
Cleared
Jan 31, 2011
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
89d
Cleared
Jan 14, 2011
MULTIPURPOSE DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
59d
Cleared
Jan 14, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
87d
Cleared
Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
7d
Cleared
Jan 11, 2011
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
FAS
Electrode, Electrosurgical, Active, Urological
106d
Cleared
Dec 30, 2010
IRRIGATION SYSTEM
OCX
Endoscopic Irrigation/suction System
58d
Cleared
Dec 27, 2010
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
KNW
Instrument, Biopsy
41d
Cleared
Dec 23, 2010
US ENDOSCOPY CYTOLOGY BRUSH
FDX
Endoscopic Cytology Brush
30d
Cleared
Dec 23, 2010
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
OCX
Endoscopic Irrigation/suction System
51d
Cleared
Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
62d
Cleared
Dec 22, 2010
RESOLUTION II CLIP
PKL
Hemostatic Metal Clip For The Gi Tract
89d
Cleared
Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
121d
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