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
607 Gastroenterology & Urology devices
Cleared
Jan 30, 2026
BAROguard Donor Lung Preservation System
KDN
System, Perfusion, Kidney
30d
Cleared
Jan 30, 2026
Disposable Distal End Tape Hood
FDF
Colonoscope And Accessories, Flexible/rigid
178d
Cleared
Jan 29, 2026
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
114d
Cleared
Jan 29, 2026
Medical Shaver System (Morcellator) (YSB-IIIA)
GCJ
Laparoscope, General & Plastic Surgery
220d
Cleared
Jan 29, 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
EZD
Catheter, Straight
280d
Cleared
Jan 28, 2026
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
121d
Cleared
Jan 26, 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
118d
Cleared
Jan 23, 2026
Elitone for Men
QAJ
Cutaneous Electrode Stimulator For Urinary Incontinence
116d
Cleared
Jan 20, 2026
Rusch SoftSimplastic Foley Catheters
EZL
Catheter, Retention Type, Balloon
161d
Cleared
Jan 20, 2026
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G
FBN
Choledochoscope And Accessories, Flexible/rigid
265d
Cleared
Jan 16, 2026
VITAL Tubing Sets for Hemodialysis
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
261d
Not Cleared
Jan 15, 2026
VitaSmart Hypothermic Oxygenated Perfusion System
SGY
Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
290d
Cleared
Jan 12, 2026
Break Wave
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
122d
Cleared
Jan 07, 2026
PuraStat
PHN
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
30d
Cleared
Jan 02, 2026
Ready to use Nelaton Catheter
EZD
Catheter, Straight
261d
Cleared
Dec 29, 2025
Niti-S Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
262d
Cleared
Dec 22, 2025
SKOUT system
QNP
Gastrointesinal Lesion Software Detection System
32d
Cleared
Dec 22, 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
FGE
Stents, Drains And Dilators For The Biliary Ducts
264d
Cleared
Dec 19, 2025
CE Deliver (DLV)
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
134d
Cleared
Dec 19, 2025
Endura™ Ureteral Stent and Stent Set
FAD
Stent, Ureteral
220d
Cleared
Dec 18, 2025
FX CorAL 40
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
36d
Cleared
Dec 18, 2025
OTSCneo System Set (100.03n-14n, 100.27n-31n)
PKL
Hemostatic Metal Clip For The Gi Tract
210d
Cleared
Dec 18, 2025
Single Use Cytology Brush V (BC-V600P-3010)
FDX
Endoscopic Cytology Brush
262d
Cleared
Dec 16, 2025
Single-use Digital Flexible Ureteroscope (GY-UR9.3)
FGB
Ureteroscope And Accessories, Flexible/rigid
132d
Cleared
Dec 16, 2025
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3)
FGB
Ureteroscope And Accessories, Flexible/rigid
174d
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