FDA Review Panel · GU

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
5372 Gastroenterology & Urology devices
2451–2475 of 5372
Cleared Jul 01, 2002
RUSCH FLONEIL
K020714 · Rusch Intl.
GBM · Catheter, Urethral · 118d
Cleared Jun 28, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K021345 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 60d
Cleared May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
K020315 · Medcomp
MSD · Catheter, Hemodialysis, Implanted · 115d
Cleared May 22, 2002
MEDCOMP ASH SPLIT-CATH II
K020465 · Medcomp
MSD · Catheter, Hemodialysis, Implanted · 99d
Cleared May 22, 2002
APPLIED URETERAL CATHETER
K020577 · Applied Medical Resources Corp.
EYB · Catheter, Ureteral, Gastro-urology · 90d
Cleared May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 23d
Cleared May 08, 2002
WILSON-COOK ZILVER BILIARY STENT
K020788 · Wilson-Cook Medical, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 58d
Cleared May 02, 2002
GIVEN DIAGNOSTIC SYSTEM
K020341 · Given Imaging , Ltd.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 90d
Cleared May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc.
FAJ · Cystoscope And Accessories, Flexible/rigid · 30d
Cleared Apr 29, 2002
REPROCESSED GUIDEWIRES
K012556 · Sterilmed, Inc.
NML · Catheter, Biliary, Reprocessed · 264d
Cleared Apr 17, 2002
NXSTAGE THERAPY SYSTEM
K020858 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 30d
Cleared Apr 12, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824 · Boston Scientific Corp
FHN · Ligator, Hemorrhoidal · 29d
Cleared Apr 09, 2002
STRATASIS SLING KIT
K020654 · Cook Biotech, Inc.
PAG · Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 40d
Cleared Apr 03, 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · Boston Scientific
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 82d
Cleared Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Mar 28, 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 27d
Cleared Mar 19, 2002
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · Hollister, Inc.
HIR · Perineometer · 134d
Cleared Mar 05, 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · Hollister, Inc.
HIR · Perineometer · 119d
Cleared Mar 04, 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 312d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · Rusch Intl.
KNT · Tubes, Gastrointestinal (and Accessories) · 347d
Cleared Feb 26, 2002
RUSCH CANTOR TUBE
K010798 · Rusch Intl.
KNT · Tubes, Gastrointestinal (and Accessories) · 347d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · E-Z-Em, Inc.
FCX · Insufflator, Automatic Carbon-dioxide For Endoscope · 146d
Cleared Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · Sterilmed, Inc.
FFL · Dislodger, Stone, Basket, Ureteral, Metal · 189d
Cleared Feb 14, 2002
REPROCESSED ENDOSCOPIC ELECTRODES
K012685 · Sterilmed, Inc.
NLW · Electrode, Electrosurgical, Active, Urological, Reprocessed · 184d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 5372 FGE Stents, Drains And Dilators For The Biliary Ducts 314 KNT Tubes, Gastrointestinal (and Accessories) 301 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 217 KOD Catheter, Urological 129 KNW Instrument, Biopsy 122 KOC Accessories, Blood Circuit, Hemodialysis 121 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 116 FJI Dialyzer, Capillary, Hollow Fiber 96 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 94 FAD Stent, Ureteral 94 FGB Ureteroscope And Accessories, Flexible/rigid 89 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 81 FDF Colonoscope And Accessories, Flexible/rigid 71 EXB Collector, Ostomy 68 FED Endoscopic Access Overtube, Gastroenterology-urology 67