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
5364 Gastroenterology & Urology devices
Cleared
Apr 30, 2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
KNT
Tubes, Gastrointestinal (and Accessories)
96d
Cleared
Apr 30, 2019
Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
PNR
Enteral Syringes With Enteral Specific Connectors
131d
Cleared
Apr 29, 2019
Magnetic Surgical System
PNL
Magnetic Surgical System
117d
Cleared
Apr 25, 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
294d
Cleared
Apr 23, 2019
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
43d
Cleared
Apr 23, 2019
Flexible HD Cysto-Urethroscope System
FAJ
Cystoscope And Accessories, Flexible/rigid
207d
Cleared
Apr 23, 2019
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
FAD
Stent, Ureteral
273d
Cleared
Apr 19, 2019
CapsoCam Plus (SV-3)
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
151d
Cleared
Apr 17, 2019
Andorate Auxiliary Water Connector
OCX
Endoscopic Irrigation/suction System
169d
Cleared
Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
FAE
Prosthesis, Penile
111d
Cleared
Apr 16, 2019
Avulsion Forceps
KGE
Forceps, Biopsy, Electric
126d
Cleared
Apr 15, 2019
Rigi10 Malleable Penile Prosthesis
FAE
Prosthesis, Penile
294d
Not Cleared
Apr 12, 2019
Plenity
QFQ
Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss
148d
Cleared
Apr 11, 2019
ELRA Electrode
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
283d
Cleared
Apr 10, 2019
PUMA-G System
KGC
Tube, Gastro-enterostomy
159d
Cleared
Apr 09, 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
55d
Cleared
Apr 04, 2019
CleverLock Guidewire Locking Device and Biopsy Cap
ODC
Endoscope Channel Accessory
63d
Cleared
Apr 02, 2019
FUJIFILM Endoscope Model EG-740N
FDS
Gastroscope And Accessories, Flexible/rigid
175d
Cleared
Mar 29, 2019
Pusen Eview Medical Video Endoscope Image Processor
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
16d
Cleared
Mar 29, 2019
Micro Transgastric-Jejunal Feeding Device
KNT
Tubes, Gastrointestinal (and Accessories)
101d
Cleared
Mar 29, 2019
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
NHV
System, Water Purification, General Medical Use
231d
Cleared
Mar 28, 2019
FUJIFILM Duodenoscope Model
FDT
Duodenoscope And Accessories, Flexible/rigid
269d
Cleared
Mar 27, 2019
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
LJE
Catheter, Nephrostomy
268d
Cleared
Mar 25, 2019
Rezum Delivery Device, Rezum Generator
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
66d
Cleared
Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
252d
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