FDA 510(k) Gastroenterology & Urology Devices
About Gastroenterology & Urology Devices
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
9824
Total
9777
Cleared
130d
Avg days
1976
Since
614 Gastroenterology & Urology devices
Cleared
Jun 21, 2023
Habib EndoHPB
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
26d
Cleared
Jun 16, 2023
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
KOC
Accessories, Blood Circuit, Hemodialysis
112d
Cleared
Jun 15, 2023
WallFlex™ Biliary RX Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
210d
Cleared
Jun 14, 2023
Niti-S Duodenal Stent
MUM
Stent, Metallic, Expandable, Duodenal
264d
Cleared
May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
526d
Cleared
May 30, 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
FCG
Biopsy Needle
60d
Cleared
May 26, 2023
Niti-S Biliary Speed D Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
172d
Cleared
May 22, 2023
PVC Hydrophilic Urethral Catheter
EZD
Catheter, Straight
434d
Cleared
May 18, 2023
Single-Use Flexible Ureteroscope
FGB
Ureteroscope And Accessories, Flexible/rigid
113d
Cleared
May 11, 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
423d
Cleared
May 04, 2023
SOZO Pro
QJB
Adjunct Monitor, Protein Calorie Malnutrition
66d
Cleared
May 04, 2023
SOZO Pro
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
66d
Cleared
May 04, 2023
SimPro™ Now, GentleCath™ Hydrophilic
EZD
Catheter, Straight
140d
Cleared
May 03, 2023
Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
265d
Cleared
May 02, 2023
ASEPT Peritoneal Drainage System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
315d
Cleared
Apr 26, 2023
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
243d
Cleared
Apr 14, 2023
EndoflipTM 300
FFX
System, Gastrointestinal Motility (electrical)
123d
Cleared
Apr 05, 2023
Optimos™ Cystotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
166d
Cleared
Mar 17, 2023
KARL STORZ Bipolar Resectoscopes with HF Cable
FJL
Resectoscope
261d
Cleared
Mar 03, 2023
Polypectomy Snare
FDI
Snare, Flexible
263d
Cleared
Mar 01, 2023
Endo SmartCap
FAJ
Cystoscope And Accessories, Flexible/rigid
153d
Cleared
Feb 22, 2023
Delta III Pro
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
237d
Cleared
Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101
FGB
Ureteroscope And Accessories, Flexible/rigid
92d
Cleared
Feb 16, 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
FBN
Choledochoscope And Accessories, Flexible/rigid
240d
Cleared
Feb 15, 2023
Altis Single Incision Sling System
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
232d
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