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
617 Gastroenterology & Urology devices
Cleared
Jan 20, 2022
Disposable Dual Action Tissue Clip
PKL
Hemostatic Metal Clip For The Gi Tract
143d
Cleared
Jan 14, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
FJS
Catheter, Peritoneal, Long-term Indwelling
60d
Cleared
Dec 20, 2021
AdVance XP Male Sling System
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
188d
Cleared
Dec 14, 2021
Aspira Peritoneal Drainage System
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
112d
Cleared
Dec 06, 2021
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
90d
Cleared
Dec 03, 2021
Everyway Incontinence Stimulation System
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
67d
Cleared
Dec 01, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
247d
Cleared
Nov 23, 2021
Uretero1 Ureteroscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
204d
Cleared
Nov 22, 2021
Agile Esophageal OTW Stent System
ESW
Prosthesis, Esophageal
151d
Cleared
Nov 10, 2021
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
138d
Cleared
Oct 29, 2021
Balloon BS-3
FDA
Enteroscope And Accessories
30d
Cleared
Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
FDS
Gastroscope And Accessories, Flexible/rigid
271d
Cleared
Oct 19, 2021
U9000 Plus Ultrafilter
FIP
Subsystem, Water Purification
195d
Cleared
Oct 07, 2021
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
FDI
Snare, Flexible
29d
Cleared
Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
PCV
Endoscopic Leak Tester
79d
Cleared
Sep 30, 2021
Enteral Pump Syringe
PNR
Enteral Syringes With Enteral Specific Connectors
129d
Cleared
Sep 03, 2021
KARL STORZ Flexible HD Cysto-Urethroscope System
FAJ
Cystoscope And Accessories, Flexible/rigid
28d
Cleared
Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
ODC
Endoscope Channel Accessory
210d
Cleared
Aug 25, 2021
Instinct Plus Endoscopic Clipping Device
PKL
Hemostatic Metal Clip For The Gi Tract
30d
Cleared
Aug 19, 2021
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
FDS
Gastroscope And Accessories, Flexible/rigid
28d
Cleared
Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
89d
Cleared
Jul 01, 2021
GlidePath Retro Long-Term Hemodialysis Catheter
MSD
Catheter, Hemodialysis, Implanted
206d
Cleared
Jun 14, 2021
URO-TOUCH 9 French Probe
FFK
Lithotriptor, Electro-hydraulic
263d
Cleared
Jun 04, 2021
GlidePath 13F Long-Term Hemodialysis Catheter
MSD
Catheter, Hemodialysis, Implanted
29d
Cleared
May 26, 2021
SpyGlass Discover Retrieval Basket
LQR
Dislodger, Stone, Biliary
195d
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