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
153d
Avg (2y)
1976
Since
2366 Gastroenterology & Urology devices
Cleared
Oct 23, 1995
KSEA REVERSE VIDEO
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
146d
Cleared
Oct 19, 1995
XENON NOPPVA
GCT
Light Source, Endoscope, Xenon Arc
17d
Cleared
Sep 13, 1995
DILATATION CATHETER, BALLOON
EZN
Dilator, Catheter, Ureteral
77d
Cleared
Aug 10, 1995
DILATATION CATHETER, BALLOON
LJE
Catheter, Nephrostomy
44d
Cleared
Aug 02, 1995
INJECTION NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
16d
Cleared
Jul 20, 1995
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS
FJL
Resectoscope
45d
Cleared
Jul 19, 1995
XXL BALLOON DILATATION CATHETER
KNQ
Dilator, Esophageal
72d
Cleared
Jun 29, 1995
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
317d
Cleared
Jun 15, 1995
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
LQR
Dislodger, Stone, Biliary
38d
Cleared
May 17, 1995
STONE DISLODGER, BASKET
FGO
Dislodger, Stone, Flexible
56d
Cleared
May 12, 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES
FGC
Urethroscope
161d
Cleared
May 03, 1995
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
FBO
Cystourethroscope
191d
Cleared
May 03, 1995
BAXTER BIOSTAT 1000 UREA MONITOR
KXM
System Accessories, Extracorporeal
909d
Cleared
Apr 28, 1995
SILASTIC BRAND FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
49d
Cleared
Apr 27, 1995
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
71d
Cleared
Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
80d
Cleared
Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
83d
Cleared
Apr 27, 1995
BARD FLEXIBLE TIP URETERAL CATHETER
EYB
Catheter, Ureteral, Gastro-urology
92d
Cleared
Apr 13, 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
KNT
Tubes, Gastrointestinal (and Accessories)
281d
Cleared
Apr 11, 1995
ENDOSCOPIC BILIARY CATHETER
LQR
Dislodger, Stone, Biliary
102d
Cleared
Apr 05, 1995
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
KOC
Accessories, Blood Circuit, Hemodialysis
71d
Cleared
Mar 30, 1995
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
FDI
Snare, Flexible
52d
Cleared
Mar 29, 1995
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
55d
Cleared
Mar 28, 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
KGE
Forceps, Biopsy, Electric
182d
Cleared
Mar 22, 1995
KARL STORZ PLASTIC SURGERY ACCESSORIES
GCM
Endoscope, Rigid
111d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices