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
Dec 19, 2024
Monoject™ Enteral Syringe with ENFit Connector (401SE)
PNR
Enteral Syringes With Enteral Specific Connectors
23d
Cleared
Dec 19, 2024
Nutrifit
FPD
Tube, Feeding
51d
Cleared
Dec 18, 2024
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R)
FAJ
Cystoscope And Accessories, Flexible/rigid
114d
Cleared
Dec 17, 2024
Tornus ES
FGE
Stents, Drains And Dilators For The Biliary Ducts
179d
Cleared
Dec 17, 2024
Cntrl+ Bladder Support Pessary
HHW
Pessary, Vaginal
270d
Cleared
Dec 16, 2024
Extraction Basket
LQR
Dislodger, Stone, Biliary
38d
Cleared
Dec 13, 2024
Uro-G HD Cystoscope (1520)
FAJ
Cystoscope And Accessories, Flexible/rigid
73d
Cleared
Dec 13, 2024
Gastro Concepts Air Assist
FER
Anoscope And Accessories
99d
Cleared
Dec 12, 2024
Aqua Medical RF Vapor Ablation System
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
220d
Cleared
Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
74d
Cleared
Dec 06, 2024
NanoKnife Generator (H78720300301US0)
OAB
Low Energy Direct Current Thermal Ablation System
91d
Cleared
Dec 06, 2024
RED
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
123d
Cleared
Dec 06, 2024
PeritX™ 1L Drainage Kit (90-1010)
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
156d
Cleared
Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
FDS
Gastroscope And Accessories, Flexible/rigid
220d
Cleared
Dec 04, 2024
CapsoCam Plus (SV-3) Capsule Endoscopy System
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
92d
Cleared
Nov 27, 2024
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
FBO
Cystourethroscope
26d
Cleared
Nov 27, 2024
Pelvic Floor Stimulator (Intrelief PFE)
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
152d
Cleared
Nov 26, 2024
SureCath Set
EZD
Catheter, Straight
137d
Cleared
Nov 26, 2024
LungProtect
KDN
System, Perfusion, Kidney
264d
Cleared
Nov 22, 2024
Entarik NI Feeding Tube System
KNT
Tubes, Gastrointestinal (and Accessories)
210d
Cleared
Nov 21, 2024
Luja Coude
EZD
Catheter, Straight
205d
Cleared
Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
51d
Cleared
Nov 12, 2024
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
FED
Endoscopic Access Overtube, Gastroenterology-urology
111d
Cleared
Nov 08, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
ODC
Endoscope Channel Accessory
42d
Cleared
Nov 01, 2024
Over-tube (TR-1108A)
FED
Endoscopic Access Overtube, Gastroenterology-urology
32d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices