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
8396 Gastroenterology & Urology devices
Cleared
Jun 24, 2011
SUPRIS RETROPUBIC SLING SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
53d
Cleared
Jun 21, 2011
TENSCARE ITOUCH SURE MODEL ITS
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
183d
Cleared
Jun 17, 2011
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
ODC
Endoscope Channel Accessory
136d
Cleared
Jun 17, 2011
PRISMAFLEX
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
85d
Cleared
Jun 16, 2011
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
KNW
Instrument, Biopsy
57d
Cleared
Jun 15, 2011
COLONOSCOPY ASSISTANT
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
253d
Cleared
Jun 10, 2011
DEFENDO Y-OPSY IRRIGATOR
ODC
Endoscope Channel Accessory
149d
Cleared
Jun 10, 2011
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
67d
Cleared
Jun 08, 2011
J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
KNW
Instrument, Biopsy
70d
Cleared
Jun 08, 2011
MULTIPURPOSE DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jun 07, 2011
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
EZD
Catheter, Straight
231d
Cleared
Jun 03, 2011
ACE STAPLER AND CARTRIDGE
OCW
Endoscopic Tissue Approximation Device
71d
Cleared
May 27, 2011
MEDAX UNIPERSONALE SRL
KNW
Instrument, Biopsy
661d
Cleared
May 27, 2011
DIRECTVISION CATHETER, UNCOATED
EZL
Catheter, Retention Type, Balloon
122d
Cleared
May 25, 2011
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
268d
Cleared
May 23, 2011
GELPOINT PATH
FER
Anoscope And Accessories
63d
Cleared
May 20, 2011
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
141d
Cleared
May 20, 2011
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
FIP
Subsystem, Water Purification
80d
Cleared
May 16, 2011
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
FFL
Dislodger, Stone, Basket, Ureteral, Metal
228d
Cleared
May 13, 2011
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
213d
Cleared
May 13, 2011
VR MEDICAL ENTERAL ORAL SYRINGE
FPD
Tube, Feeding
46d
Cleared
May 12, 2011
UPD-Y0003
FDF
Colonoscope And Accessories, Flexible/rigid
183d
Cleared
May 12, 2011
MUSTANG BALLOON DILATAION CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
114d
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
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