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
Oct 16, 2025
NeurAxis IB-Stim (01-1020)
QHH
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
108d
Cleared
Oct 10, 2025
EvoEndo Single-Use Endoscopy System
FDS
Gastroscope And Accessories, Flexible/rigid
129d
Cleared
Oct 10, 2025
HYDROS Robotic System (HY1000)
PZP
Fluid Jet Removal System
184d
Cleared
Oct 10, 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
245d
Cleared
Oct 09, 2025
Orca Air/Water and Suction Valves
ODC
Endoscope Channel Accessory
27d
Cleared
Oct 09, 2025
DIASAFEplusUS (F00013010)
FIP
Subsystem, Water Purification
115d
Cleared
Oct 09, 2025
SleeveLUX 24 Anoscope/Proctoscope (P2001)
FER
Anoscope And Accessories
219d
Cleared
Oct 07, 2025
Prodeon Urethral Sheath System
FED
Endoscopic Access Overtube, Gastroenterology-urology
54d
Cleared
Oct 07, 2025
Disposable Hot Biopsy Forceps (FD-210U)
KGE
Forceps, Biopsy, Electric
258d
Cleared
Oct 06, 2025
Heylo™ System
EXB
Collector, Ostomy
90d
Cleared
Oct 03, 2025
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
FGB
Ureteroscope And Accessories, Flexible/rigid
30d
Cleared
Oct 03, 2025
MAGENTIQ-COLO (ME-APDS)
QNP
Gastrointesinal Lesion Software Detection System
84d
Cleared
Oct 03, 2025
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
108d
Cleared
Oct 03, 2025
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
EZD
Catheter, Straight
143d
Cleared
Oct 02, 2025
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
146d
Cleared
Oct 02, 2025
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1)
FKX
System, Peritoneal, Automatic Delivery
223d
Cleared
Sep 29, 2025
SureTome™ SW Sphincterotome with DomeTip
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
171d
Cleared
Sep 26, 2025
AUXILIARY WATER TUBE MAJ-855
OCX
Endoscopic Irrigation/suction System
91d
Cleared
Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
FDA
Enteroscope And Accessories
161d
Cleared
Sep 26, 2025
LoFric Origo
EZD
Catheter, Straight
205d
Cleared
Sep 25, 2025
Single-Use Biopsy Valve (MAJ-1555)
OCX
Endoscopic Irrigation/suction System
90d
Cleared
Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000)
FGB
Ureteroscope And Accessories, Flexible/rigid
28d
Cleared
Sep 24, 2025
ProVee Video Processing Unit (PV-003)
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
110d
Cleared
Sep 24, 2025
ROBOPERA (ER-R-002)
FDF
Colonoscope And Accessories, Flexible/rigid
268d
Cleared
Sep 23, 2025
Zenflow Spring Scope
FAJ
Cystoscope And Accessories, Flexible/rigid
162d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices