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
8400 Gastroenterology & Urology devices
Cleared
May 20, 2010
ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET
KNT
Tubes, Gastrointestinal (and Accessories)
266d
Cleared
May 20, 2010
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
KNT
Tubes, Gastrointestinal (and Accessories)
97d
Cleared
May 20, 2010
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
NDS
Media, Culture, Ex Vivo, Tissue And Cell
77d
Cleared
May 20, 2010
DESARA MESH MODEL: CAL-DS01
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
24d
Cleared
May 19, 2010
DISPOSABLE SUCTION AND IRRIGATION SYSTEM
FHF
System, Evacuator, Fluid
191d
Cleared
May 17, 2010
CLEARJET
ODC
Endoscope Channel Accessory
27d
Cleared
May 11, 2010
ACE STAPLER, MODEL F0031
OCW
Endoscopic Tissue Approximation Device
662d
Cleared
May 10, 2010
REDSENSE-HOME USE
ODX
Autonomous Extracorporeal Blood Leak Detector/alarm
227d
Cleared
May 07, 2010
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
154d
Cleared
May 06, 2010
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
OCS
Endoscopic Video Imaging System/component, Gastroenterology-urology
41d
Cleared
Apr 30, 2010
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
FFK
Lithotriptor, Electro-hydraulic
298d
Cleared
Apr 29, 2010
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
KNW
Instrument, Biopsy
132d
Cleared
Apr 23, 2010
DIALYSATE METER, MODEL D-6
FLB
Meter, Conductivity, Induction, Remote Type
87d
Cleared
Apr 22, 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
KNT
Tubes, Gastrointestinal (and Accessories)
83d
Cleared
Apr 22, 2010
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
76d
Cleared
Apr 22, 2010
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
FPD
Tube, Feeding
57d
Cleared
Apr 22, 2010
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
FEQ
Pump, Air, Non-manual, For Endoscope
31d
Cleared
Apr 16, 2010
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
KNT
Tubes, Gastrointestinal (and Accessories)
85d
Cleared
Apr 12, 2010
ENTEROSCOPY OVERTUBE, MODEL 00712140
FED
Endoscopic Access Overtube, Gastroenterology-urology
90d
Cleared
Apr 02, 2010
VITALA CONTINENCE CONTROL DEVICE
EZQ
Pouch, Colostomy
469d
Cleared
Apr 02, 2010
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
FIP
Subsystem, Water Purification
232d
Cleared
Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
FCG
Biopsy Needle
18d
Cleared
Mar 25, 2010
DBB-06 HEMODIALYSIS DELIVERY SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
267d
Cleared
Mar 25, 2010
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
FER
Anoscope And Accessories
97d
Cleared
Mar 24, 2010
BONASTENT BILIARY
FGE
Stents, Drains And Dilators For The Biliary Ducts
177d
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