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
5369 Gastroenterology & Urology devices
Cleared
Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
15d
Cleared
Jun 24, 2005
NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
114d
Cleared
Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
KNW
Instrument, Biopsy
22d
Cleared
Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
FED
Endoscopic Access Overtube, Gastroenterology-urology
9d
Cleared
Jun 13, 2005
SERIM DIALYSATE MONITOR TEST STRIP
NTZ
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
222d
Cleared
Jun 13, 2005
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
84d
Cleared
Jun 08, 2005
FRESENIUS ART HEMOADSORPTION SYSTEM
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
121d
Cleared
Jun 03, 2005
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
EZD
Catheter, Straight
151d
Cleared
May 26, 2005
U-BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
50d
Cleared
May 23, 2005
REPROCESSED ENDOSCOPIC TROCAR
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
145d
Cleared
May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
79d
Cleared
May 16, 2005
ENCOR 7 GAUGE
KNW
Instrument, Biopsy
11d
Cleared
May 12, 2005
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
FCG
Biopsy Needle
73d
Cleared
May 11, 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
174d
Cleared
May 05, 2005
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
GBM
Catheter, Urethral
29d
Cleared
Apr 22, 2005
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
46d
Cleared
Apr 22, 2005
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
FGE
Stents, Drains And Dilators For The Biliary Ducts
25d
Cleared
Apr 12, 2005
EVADRI BLADDER CONTROL SYSTEMS
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
47d
Cleared
Apr 08, 2005
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
135d
Cleared
Apr 06, 2005
TEGRESS IMPLANT NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
20d
Cleared
Apr 04, 2005
AIDA WITH DICOM AND HL7 INTERFACE
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
123d
Cleared
Mar 31, 2005
FRESENIUS LIBERTY CYCLER
FKX
System, Peritoneal, Automatic Delivery
114d
Cleared
Mar 31, 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
FED
Endoscopic Access Overtube, Gastroenterology-urology
108d
Cleared
Mar 31, 2005
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
92d
Cleared
Mar 31, 2005
COOK IRELAND SONNET POLYPECTOMY SNARE
FDI
Snare, Flexible
52d
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