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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8400 Gastroenterology & Urology devices
Cleared
Jul 23, 2010
MINI-TONG
OCW
Endoscopic Tissue Approximation Device
94d
Cleared
Jul 23, 2010
GUARDIAN CONNECTION
FPD
Tube, Feeding
84d
Cleared
Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
73d
Cleared
Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jul 19, 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jul 16, 2010
WATER BOTTLE CAP SYSTEM
FEQ
Pump, Air, Non-manual, For Endoscope
84d
Cleared
Jul 15, 2010
THD BANDY
FHN
Ligator, Hemorrhoidal
245d
Cleared
Jul 14, 2010
OLYMPUS CF TYPE Y0023-L, Y0023I
FDF
Colonoscope And Accessories, Flexible/rigid
90d
Cleared
Jul 09, 2010
VENOFER PUMP
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
197d
Cleared
Jul 02, 2010
MEDLINE PVC URETHRAL CATHETER
EZD
Catheter, Straight
149d
Cleared
Jul 02, 2010
EVIS EXERAII 180 SYSTEM
NWB
Endoscope, Accessories, Narrow Band Spectrum
122d
Cleared
Jul 01, 2010
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
FAS
Electrode, Electrosurgical, Active, Urological
150d
Cleared
Jul 01, 2010
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
87d
Cleared
Jun 18, 2010
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
25d
Cleared
Jun 17, 2010
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
ESW
Prosthesis, Esophageal
206d
Cleared
Jun 14, 2010
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
FED
Endoscopic Access Overtube, Gastroenterology-urology
689d
Cleared
Jun 14, 2010
ORAL/ENTERAL SYRINGES
FPD
Tube, Feeding
152d
Cleared
Jun 14, 2010
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
KNT
Tubes, Gastrointestinal (and Accessories)
122d
Cleared
Jun 11, 2010
THE WATER LILY
KPL
Colonic Irrigation System
163d
Cleared
Jun 07, 2010
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
77d
Cleared
Jun 04, 2010
HANAROSTENT ESOPHAGUS (CCC)
ESW
Prosthesis, Esophageal
200d
Cleared
Jun 03, 2010
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
24d
Cleared
May 27, 2010
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
156d
Cleared
May 26, 2010
SELF CATH CATHETER
EZD
Catheter, Straight
57d
Cleared
May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
29d
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