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
8404 Gastroenterology & Urology devices
Cleared
Jan 21, 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jan 20, 2010
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
FAD
Stent, Ureteral
483d
Cleared
Jan 15, 2010
MODERN MEDICAL RESECTOSCOPE ELECTRODES
FAS
Electrode, Electrosurgical, Active, Urological
238d
Cleared
Jan 12, 2010
MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
ODF
Mini Endoscope, Gastroenterology-urology
126d
Cleared
Jan 08, 2010
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
MSD
Catheter, Hemodialysis, Implanted
232d
Cleared
Dec 31, 2009
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
62d
Cleared
Dec 28, 2009
PENTEX EC-3890LI
FDF
Colonoscope And Accessories, Flexible/rigid
90d
Cleared
Dec 23, 2009
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
OCV
Endoscope Holder
34d
Cleared
Dec 15, 2009
ENDOFLIP
FFX
System, Gastrointestinal Motility (electrical)
90d
Cleared
Dec 15, 2009
ENDO SMARTCAP
FAJ
Cystoscope And Accessories, Flexible/rigid
20d
Cleared
Dec 08, 2009
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
KGC
Tube, Gastro-enterostomy
47d
Cleared
Dec 04, 2009
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
14d
Cleared
Dec 02, 2009
PENTAX ED-3490TK, VIDEO DUODENOSCOPE
FDT
Duodenoscope And Accessories, Flexible/rigid
90d
Cleared
Dec 02, 2009
INSERTEASE
OOW
Applicator For Rectal Suppository
78d
Cleared
Nov 30, 2009
ERBELIFT HAND PUMP AND FLEXIBLE PROBE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
139d
Cleared
Nov 25, 2009
MULTI-BITE HOT BIOPSY FORCEPS
KGE
Forceps, Biopsy, Electric
246d
Cleared
Nov 23, 2009
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
340d
Cleared
Nov 20, 2009
AJUST ADJUSTABLE SINGLE INCISION SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
87d
Cleared
Nov 20, 2009
ENCOR BREAST BIOPSY SYSTEM
KNW
Instrument, Biopsy
7d
Cleared
Nov 19, 2009
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
248d
Cleared
Nov 19, 2009
ENDOGATOR
FEQ
Pump, Air, Non-manual, For Endoscope
104d
Cleared
Nov 19, 2009
ACUTE AND CHRONIC CATHETER REPAIR KIT
NFK
Kit, Repair, Catheter, Hemodialysis
69d
Cleared
Nov 19, 2009
PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
KNW
Instrument, Biopsy
17d
Cleared
Nov 17, 2009
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
KNW
Instrument, Biopsy
29d
Cleared
Nov 12, 2009
CENTROS CHRONIC HEMODIALYSIS CATHETER SET
MSD
Catheter, Hemodialysis, Implanted
80d
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