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
Apr 04, 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
116d
Cleared
Apr 03, 2025
stay•safe® catheter extension set with Safe- Lock, 12 inch
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
50d
Cleared
Mar 31, 2025
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
MUM
Stent, Metallic, Expandable, Duodenal
26d
Cleared
Mar 31, 2025
Belzer UW® Cold Storage Solution (BTLBUW-001)
KDN
System, Perfusion, Kidney
151d
Cleared
Mar 28, 2025
Flexi-Seal AIR (with ENFit Connector)
KNT
Tubes, Gastrointestinal (and Accessories)
171d
Cleared
Mar 27, 2025
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P
FGB
Ureteroscope And Accessories, Flexible/rigid
115d
Cleared
Mar 27, 2025
Levina Pelvic Floor Muscle Stimulator (RS-48)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
273d
Cleared
Mar 26, 2025
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
KDN
System, Perfusion, Kidney
103d
Cleared
Mar 26, 2025
SB Knife Jr2 (MD-47702 and MD-47702L)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
272d
Cleared
Mar 24, 2025
Glean Urodynamics System Male Delivery System (GUS-1000-M)
EXQ
Cystometer, Electrical Recording
178d
Cleared
Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
FED
Endoscopic Access Overtube, Gastroenterology-urology
28d
Cleared
Mar 21, 2025
EHL Probe (SCDG-AS)
FFK
Lithotriptor, Electro-hydraulic
175d
Cleared
Mar 21, 2025
Electrohydraulic Lithotriptor (TCS-B3-II)
FFK
Lithotriptor, Electro-hydraulic
179d
Cleared
Mar 21, 2025
FX CorAL 40 (F00009214)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
252d
Cleared
Mar 20, 2025
Endoscopic Water Pump
OCX
Endoscopic Irrigation/suction System
280d
Cleared
Mar 19, 2025
Luer-Split MAJ-2092
ODC
Endoscope Channel Accessory
266d
Cleared
Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
LQR
Dislodger, Stone, Biliary
97d
Cleared
Mar 17, 2025
UPT Series Medical RO Water Treatment System
FIP
Subsystem, Water Purification
24d
Cleared
Mar 07, 2025
Flexible Video-Choledochoscope (CHV-110J-U)
FBN
Choledochoscope And Accessories, Flexible/rigid
112d
Cleared
Mar 05, 2025
Wellead® Hydrophilic Intermittent Catheter Ready to Use
GBM
Catheter, Urethral
261d
Cleared
Feb 28, 2025
FX CorAL 60 (F00012969)
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
73d
Cleared
Feb 27, 2025
Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
KNW
Instrument, Biopsy
223d
Cleared
Feb 20, 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
ODC
Endoscope Channel Accessory
34d
Cleared
Feb 12, 2025
Fecobionics Anorectal System
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
160d
Cleared
Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
FGB
Ureteroscope And Accessories, Flexible/rigid
134d
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