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
609 Gastroenterology & Urology devices
Cleared
Jun 13, 2025
2008T HD SYS. CDX BLUESTAR (191124)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
246d
Cleared
Jun 11, 2025
Rezum System
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
104d
Cleared
Jun 11, 2025
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
FAJ
Cystoscope And Accessories, Flexible/rigid
132d
Cleared
Jun 10, 2025
FUJIFILM Endoscope Model EG-840N
FDS
Gastroscope And Accessories, Flexible/rigid
210d
Cleared
Jun 06, 2025
Cure Catheter Insertion Kit (K1)
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
73d
Cleared
Jun 06, 2025
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
FGB
Ureteroscope And Accessories, Flexible/rigid
203d
Cleared
Jun 06, 2025
SpydrBlade Flex Instrument (PRD-RG1-001)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
266d
Cleared
Jun 05, 2025
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
FDT
Duodenoscope And Accessories, Flexible/rigid
90d
Cleared
Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
53d
Cleared
Jun 02, 2025
CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
FED
Endoscopic Access Overtube, Gastroenterology-urology
104d
Cleared
May 30, 2025
5008X Hemodialysis System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
199d
Cleared
May 30, 2025
Endoscopic Distal Attachment (AF-D series)
FDS
Gastroscope And Accessories, Flexible/rigid
269d
Cleared
May 28, 2025
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US)
FGB
Ureteroscope And Accessories, Flexible/rigid
261d
Cleared
May 27, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
90d
Cleared
May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
FDF
Colonoscope And Accessories, Flexible/rigid
220d
Cleared
May 22, 2025
Optilume® High Pressure Urological Balloon Dilation Catheter
EZN
Dilator, Catheter, Ureteral
57d
Cleared
May 22, 2025
ArgoCap (200.52)
OCX
Endoscopic Irrigation/suction System
265d
Cleared
May 21, 2025
MotiliCap GI Monitoring System
NYV
Gastrointestinal Motility System, Capsule
90d
Cleared
May 21, 2025
ClearHemograsper
KGE
Forceps, Biopsy, Electric
243d
Cleared
May 16, 2025
Byonyks X-1 APD Cycler
FKX
System, Peritoneal, Automatic Delivery
198d
Cleared
May 16, 2025
Hemodialysis Catheter
MSD
Catheter, Hemodialysis, Implanted
347d
Cleared
May 15, 2025
NeurAxis IB-Stim (01-1020)
QHH
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
86d
Cleared
May 15, 2025
Colonovideoscope (CF-EZ1500DL)
FDF
Colonoscope And Accessories, Flexible/rigid
90d
Cleared
May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
KOC
Accessories, Blood Circuit, Hemodialysis
267d
Cleared
May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
KOC
Accessories, Blood Circuit, Hemodialysis
295d
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