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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8393 Gastroenterology & Urology devices
Cleared
Nov 05, 2012
ALTIS SINGLE INCISION CLING SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
160d
Cleared
Nov 02, 2012
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
24d
Cleared
Nov 01, 2012
PRESSURIZED INFUSION PUMP
FFX
System, Gastrointestinal Motility (electrical)
93d
Cleared
Oct 31, 2012
LOFRIC PRIMO, LOFRIC HYDRO-KIT
EZD
Catheter, Straight
107d
Cleared
Oct 26, 2012
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
KOB
Catheter, Suprapubic (and Accessories)
283d
Cleared
Oct 26, 2012
RENEW INSERT
PBP
Rectal Insert
109d
Cleared
Oct 24, 2012
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
76d
Cleared
Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
KNQ
Dilator, Esophageal
30d
Cleared
Oct 10, 2012
BLUE SUI SLING
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
118d
Cleared
Oct 09, 2012
AXCESS SOFT TIP WIRE GUIDE
OCY
Endoscopic Guidewire, Gastroenterology-urology
25d
Cleared
Oct 02, 2012
SPEEDICATH COMPACT SET (12 FR)
GBM
Catheter, Urethral
139d
Cleared
Oct 01, 2012
SPEEDICATH COMPACT SET (12/18 FR)
GBM
Catheter, Urethral
138d
Cleared
Sep 28, 2012
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
385d
Cleared
Sep 28, 2012
PEERSCOPE SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
241d
Cleared
Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
FGE
Stents, Drains And Dilators For The Biliary Ducts
74d
Cleared
Sep 28, 2012
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
FED
Endoscopic Access Overtube, Gastroenterology-urology
60d
Cleared
Sep 27, 2012
WITHINGS, SMART BODY SCALE
MNW
Analyzer, Body Composition
84d
Cleared
Sep 25, 2012
CHF-Y0005
FBN
Choledochoscope And Accessories, Flexible/rigid
340d
Cleared
Sep 24, 2012
GEMINI LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
111d
Cleared
Sep 21, 2012
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
MSD
Catheter, Hemodialysis, Implanted
88d
Cleared
Sep 20, 2012
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
FCW
Light Source, Fiberoptic, Routine
100d
Cleared
Sep 18, 2012
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
LJE
Catheter, Nephrostomy
109d
Cleared
Sep 17, 2012
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
FIP
Subsystem, Water Purification
166d
Cleared
Sep 13, 2012
PRECISION ENDOSCOPIC INFRARED COAGULATOR
FEH
Electrode, Flexible Suction Coagulator
20d
Cleared
Sep 12, 2012
STRYKER VIDEO URETEROSCOPE
FGB
Ureteroscope And Accessories, Flexible/rigid
153d
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