FDA 510(k) Gastroenterology & Urology Devices
FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview
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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5365 Gastroenterology & Urology devices
Cleared
Jan 30, 2018
Uro-V Cystoscope
FAJ
Cystoscope And Accessories, Flexible/rigid
252d
Cleared
Jan 30, 2018
MiroCam Capsule Endoscope System
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
351d
Cleared
Jan 29, 2018
Rusch Intermittent Urethral Catheters
EZC
Catheter, Coude
69d
Cleared
Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
KNT
Tubes, Gastrointestinal (and Accessories)
29d
Cleared
Jan 24, 2018
Cycler Drain Bag Set
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
90d
Cleared
Jan 19, 2018
Focus Cap
FDF
Colonoscope And Accessories, Flexible/rigid
227d
Cleared
Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
62d
Cleared
Jan 18, 2018
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
FED
Endoscopic Access Overtube, Gastroenterology-urology
143d
Cleared
Jan 18, 2018
Pelvifine Pelvic Muscle Trainer
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
422d
Cleared
Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
261d
Cleared
Jan 10, 2018
Swiss LithoClast Trilogy
FEO
Lithotriptor, Ultrasonic
97d
Cleared
Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
LJE
Catheter, Nephrostomy
107d
Cleared
Jan 10, 2018
Instalief
LKX
Device, Thermal, Hemorrhoids
160d
Cleared
Jan 08, 2018
invendoscopy E210 System
FDF
Colonoscope And Accessories, Flexible/rigid
101d
Cleared
Jan 05, 2018
AquaShield System CO2- Fujifilm
FEQ
Pump, Air, Non-manual, For Endoscope
38d
Cleared
Jan 05, 2018
EON Portable Reverse Osmosis Water Purification System
FIP
Subsystem, Water Purification
267d
Cleared
Dec 29, 2017
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDX
Endoscopic Cytology Brush
213d
Cleared
Dec 21, 2017
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
EYB
Catheter, Ureteral, Gastro-urology
258d
Cleared
Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
PWJ
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
117d
Cleared
Dec 15, 2017
Strange Bile Duct Stone Exploration Set
LQR
Dislodger, Stone, Biliary
14d
Cleared
Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
KOC
Accessories, Blood Circuit, Hemodialysis
141d
Cleared
Dec 13, 2017
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
142d
Cleared
Dec 12, 2017
Wittich Nitinol Stone Basket
LQR
Dislodger, Stone, Biliary
260d
Cleared
Dec 07, 2017
Single Use Electrosurgical Snare SD-400
FDI
Snare, Flexible
87d
Cleared
Nov 27, 2017
Single Use Retrieval Nitinol Basket V
LQR
Dislodger, Stone, Biliary
255d
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