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
5367 Gastroenterology & Urology devices
Cleared
Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
FKP
System, Dialysate Delivery, Single Patient
119d
Cleared
Oct 10, 2013
PEERSCOPE SYSTEM
FDS
Gastroscope And Accessories, Flexible/rigid
147d
Cleared
Oct 07, 2013
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
FGE
Stents, Drains And Dilators For The Biliary Ducts
161d
Cleared
Sep 18, 2013
MEDLINE ANTI-REFLUX VALVE
FEG
Tube, Double Lumen For Intestinal Decompression And/or Intubation
55d
Cleared
Aug 30, 2013
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
161d
Cleared
Aug 29, 2013
EVIS EXERA III VIDEO SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
73d
Cleared
Aug 29, 2013
FRESENIUS DRY ACID DISSOLUTION UNITS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
87d
Cleared
Aug 23, 2013
AUTOBAND LIGATOR
MND
Ligator, Esophageal
10d
Cleared
Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
51d
Cleared
Aug 12, 2013
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
238d
Cleared
Aug 09, 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
165d
Cleared
Aug 07, 2013
FOREIGN BODY HOOD
FDS
Gastroscope And Accessories, Flexible/rigid
197d
Cleared
Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
MPB
Catheter, Hemodialysis, Non-implanted
378d
Cleared
Jul 26, 2013
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
140d
Cleared
Jul 11, 2013
NXSTAGE DOSING CALCULATOR
FKP
System, Dialysate Delivery, Single Patient
139d
Cleared
Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
OCY
Endoscopic Guidewire, Gastroenterology-urology
83d
Cleared
Jul 03, 2013
2008K@HOME HEMODIALYSIS MACHINE
ONW
Hemodialysis System For Home Use
187d
Cleared
Jun 26, 2013
HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
247d
Cleared
Jun 19, 2013
CLL- V1 LIGHT SOURCE
NTN
Led Light Source
86d
Cleared
Jun 11, 2013
T3
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
232d
Cleared
May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
EZN
Dilator, Catheter, Ureteral
58d
Cleared
May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
OCX
Endoscopic Irrigation/suction System
45d
Cleared
May 07, 2013
PUREFLUX-H HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
277d
Cleared
May 01, 2013
ELISIO-H AND ELISIO-M HEMODIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
271d
Cleared
Apr 29, 2013
SINGLE USE REPOSITIONABLE CLIP
PKL
Hemostatic Metal Clip For The Gi Tract
159d
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