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
9843
Total
9796
Cleared
153d
Avg (2y)
1976
Since
2339 Gastroenterology & Urology devices
Cleared
Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
44d
Cleared
Aug 26, 2011
COMFORTGLIDE INTERMITENT CATHETER
EZD
Catheter, Straight
31d
Cleared
Jun 16, 2011
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
KNW
Instrument, Biopsy
57d
Cleared
May 06, 2011
ASPIRA PERITONEAL DRAINAGE SYSTEM
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
84d
Cleared
Apr 20, 2011
CRE BALLOON DILATATION CATHETER
FDT
Duodenoscope And Accessories, Flexible/rigid
26d
Cleared
Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
15d
Cleared
Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
FKX
System, Peritoneal, Automatic Delivery
177d
Cleared
Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
7d
Cleared
Dec 27, 2010
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
KNW
Instrument, Biopsy
41d
Cleared
Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
62d
Cleared
Dec 22, 2010
RESOLUTION II CLIP
PKL
Hemostatic Metal Clip For The Gi Tract
89d
Cleared
Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
121d
Cleared
Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
KOD
Catheter, Urological
64d
Cleared
Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
KGE
Forceps, Biopsy, Electric
116d
Cleared
Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
85d
Cleared
Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
73d
Cleared
Jul 02, 2010
MEDLINE PVC URETHRAL CATHETER
EZD
Catheter, Straight
149d
Cleared
May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
29d
Cleared
May 07, 2010
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
154d
Cleared
Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
FCG
Biopsy Needle
18d
Cleared
Jan 21, 2010
MEDLINE RED RUBBER URETHRAL CATHETER
EYB
Catheter, Ureteral, Gastro-urology
177d
Cleared
Nov 20, 2009
AJUST ADJUSTABLE SINGLE INCISION SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
87d
Cleared
Nov 10, 2009
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
KNW
Instrument, Biopsy
41d
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