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

9843
Total
9796
Cleared
154d
Avg (2y)
1976
Since
2606 Gastroenterology & Urology devices
1626–1650 of 2606
Cleared Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
K102936 · Baxter Healthcare Corp
FKX · System, Peritoneal, Automatic Delivery · 177d
Cleared Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030 · Boston Scientific Corp
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 7d
Cleared Dec 27, 2010
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
K103359 · C.R. Bard, Inc.
KNW · Instrument, Biopsy · 41d
Cleared Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 62d
Cleared Dec 22, 2010
RESOLUTION II CLIP
K102764 · Boston Scientific Corporation
PKL · Hemostatic Metal Clip For The Gi Tract · 89d
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 121d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · Boston Scientific Corporation
KOD · Catheter, Urological · 64d
Cleared Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp
KGE · Forceps, Biopsy, Electric · 116d
Cleared Sep 07, 2010
MERIT BIPOLAR COAGULATION PROBE
K102273 · Merit Medical Systems, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 27d
Cleared Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
K102082 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 28d
Cleared Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261 · C.R. Bard, Inc.
NFK · Kit, Repair, Catheter, Hemodialysis · 85d
Cleared Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 28d
Cleared Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 73d
Cleared Jul 02, 2010
MEDLINE PVC URETHRAL CATHETER
K100302 · Medline Industries, Inc.
EZD · Catheter, Straight · 149d
Cleared Jul 01, 2010
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
K100936 · Ethicon, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 87d
Cleared May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
K101139 · Medtronic, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 29d
Cleared May 07, 2010
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
K093747 · C.R. Bard, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 154d
Cleared Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · Boston Scientific Corporation
FCG · Biopsy Needle · 18d
Cleared Mar 16, 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
K100485 · Ethicon, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 25d
Cleared Jan 21, 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · Merit Medical Systems, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Jan 21, 2010
MEDLINE RED RUBBER URETHRAL CATHETER
K092250 · Medline Industries, Inc.
EYB · Catheter, Ureteral, Gastro-urology · 177d
Cleared Nov 20, 2009
AJUST ADJUSTABLE SINGLE INCISION SLING
K092607 · C.R. Bard, Inc.
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
K093068 · C.R. Bard, Inc.
KNW · Instrument, Biopsy · 41d
Cleared Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · KARL STORZ Endoscopy-America, Inc.
FCW · Light Source, Fiberoptic, Routine · 75d
Cleared Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
K090002 · Baxter Healthcare Corp
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 217d

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All categories 2606 FGE Stents, Drains And Dilators For The Biliary Ducts 185 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 74 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 70 PKL Hemostatic Metal Clip For The Gi Tract 50 FED Endoscopic Access Overtube, Gastroenterology-urology 48 FAD Stent, Ureteral 47 ODC Endoscope Channel Accessory 47 FAJ Cystoscope And Accessories, Flexible/rigid 47 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 KNW Instrument, Biopsy 43 FDS Gastroscope And Accessories, Flexible/rigid 40