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
5367 Gastroenterology & Urology devices
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 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 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
Apr 29, 2010
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
KNW
Instrument, Biopsy
132d
Cleared
Apr 22, 2010
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
FEQ
Pump, Air, Non-manual, For Endoscope
31d
Cleared
Apr 22, 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
KNT
Tubes, Gastrointestinal (and Accessories)
83d
Cleared
Apr 12, 2010
ENTEROSCOPY OVERTUBE, MODEL 00712140
FED
Endoscopic Access Overtube, Gastroenterology-urology
90d
Cleared
Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
FCG
Biopsy Needle
18d
Cleared
Mar 25, 2010
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
FER
Anoscope And Accessories
97d
Cleared
Mar 24, 2010
BONASTENT BILIARY
FGE
Stents, Drains And Dilators For The Biliary Ducts
177d
Cleared
Mar 22, 2010
SYSTEMS INTEGRATION MODEL: ENDOALPHA
ODA
Endoscopic Central Control Unit
45d
Cleared
Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
FIE
Needle, Fistula
22d
Cleared
Mar 16, 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
25d
Cleared
Mar 10, 2010
OLYMPUS CHF TYPE Y0003
FBN
Choledochoscope And Accessories, Flexible/rigid
117d
Cleared
Feb 24, 2010
GYRUS ACMI PK BUTTON ELECTRODE
FAS
Electrode, Electrosurgical, Active, Urological
139d
Cleared
Feb 22, 2010
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
ESW
Prosthesis, Esophageal
222d
Cleared
Jan 22, 2010
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
FIE
Needle, Fistula
29d
Cleared
Jan 21, 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jan 21, 2010
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
FCG
Biopsy Needle
104d
Cleared
Jan 21, 2010
MEDLINE RED RUBBER URETHRAL CATHETER
EYB
Catheter, Ureteral, Gastro-urology
177d
Cleared
Dec 31, 2009
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
62d
Cleared
Dec 08, 2009
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
KGC
Tube, Gastro-enterostomy
47d
Cleared
Nov 23, 2009
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
340d
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