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
8420 Gastroenterology & Urology devices
Cleared
Nov 09, 2005
AQUADEX SYSTEM
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
244d
Cleared
Nov 09, 2005
B. BRAUN MODIFIED BICARBONATE DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
70d
Cleared
Nov 09, 2005
PEDIATRIC FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
26d
Cleared
Nov 07, 2005
ABBOTT SPINE, INC. SPINNAKER SYSTEM
KNW
Instrument, Biopsy
42d
Cleared
Nov 03, 2005
PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS
KNW
Instrument, Biopsy
58d
Cleared
Nov 02, 2005
Y2K2 ENTERNAL TUBE FLUID FILTER
KNT
Tubes, Gastrointestinal (and Accessories)
175d
Cleared
Nov 02, 2005
MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
76d
Cleared
Nov 01, 2005
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
KNW
Instrument, Biopsy
29d
Cleared
Oct 31, 2005
SLIMMANAGER, MODEL SM-X, SM-E
MNW
Analyzer, Body Composition
138d
Cleared
Oct 31, 2005
DSNARE, MODEL 00711087
FCK
Instrument, Biopsy, Suction
133d
Cleared
Oct 28, 2005
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
164d
Cleared
Oct 27, 2005
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
FBK
Endoscopic Injection Needle, Gastroenterology-urology
322d
Cleared
Oct 17, 2005
URGENT PC NEUROMODULATION SYSTEM
NAM
Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
82d
Cleared
Oct 17, 2005
I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
68d
Cleared
Oct 13, 2005
EVIS EXERA 160A SYSTEM
NWB
Endoscope, Accessories, Narrow Band Spectrum
115d
Cleared
Oct 12, 2005
ENTERAL FEEDING TUBE
BSS
Tube, Nasogastric
131d
Cleared
Oct 11, 2005
COOK IRELAND ECHOBRUSH
FDX
Endoscopic Cytology Brush
50d
Cleared
Oct 11, 2005
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
EZD
Catheter, Straight
35d
Cleared
Oct 06, 2005
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
MSD
Catheter, Hemodialysis, Implanted
113d
Cleared
Oct 05, 2005
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
FAJ
Cystoscope And Accessories, Flexible/rigid
152d
Cleared
Sep 30, 2005
HEMOR-RITE CRYOTHERAPHY
LKX
Device, Thermal, Hemorrhoids
374d
Cleared
Sep 22, 2005
CYSTOGLIDE DILATING INTRODUCER SHEATH
KNY
Accessories, Catheter, G-u
48d
Cleared
Sep 14, 2005
ENDO-EASE ENDOSCOPIC OVERTUBE
FED
Endoscopic Access Overtube, Gastroenterology-urology
43d
Cleared
Sep 13, 2005
ACCORDION
FFL
Dislodger, Stone, Basket, Ureteral, Metal
46d
Cleared
Sep 02, 2005
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
KNY
Accessories, Catheter, G-u
78d
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