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
2367 Gastroenterology & Urology devices
Cleared
Mar 28, 1994
ABBOTT SMART CAP
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
712d
Cleared
Mar 16, 1994
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
OCW
Endoscopic Tissue Approximation Device
166d
Cleared
Mar 15, 1994
BARD UROTRACK II MONITORING
KOC
Accessories, Blood Circuit, Hemodialysis
560d
Cleared
Mar 14, 1994
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
KNW
Instrument, Biopsy
102d
Cleared
Mar 04, 1994
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
FKX
System, Peritoneal, Automatic Delivery
617d
Cleared
Feb 22, 1994
BAXTER APD 12' EXTENSION LINE
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
487d
Cleared
Feb 14, 1994
UROLOGICAL BALLOON DILATATION CATHETER
EZN
Dilator, Catheter, Ureteral
97d
Cleared
Feb 09, 1994
KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
FJL
Resectoscope
133d
Cleared
Feb 01, 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
225d
Cleared
Jan 26, 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
502d
Cleared
Jan 25, 1994
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
FCL
Forceps, Biopsy, Non-electric
92d
Cleared
Jan 11, 1994
KARL STORZ ENDOSCOPIC COLD KNIFE BLADES
EZO
Urethrotome
102d
Cleared
Jan 03, 1994
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
EYB
Catheter, Ureteral, Gastro-urology
195d
Cleared
Dec 17, 1993
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
58d
Cleared
Dec 01, 1993
BARD ENDOSCOPIC INJECTION SYSTEM
FBK
Endoscopic Injection Needle, Gastroenterology-urology
119d
Cleared
Oct 08, 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
372d
Cleared
Sep 28, 1993
AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS
FFN
Clamp, Non-electrical
133d
Cleared
Sep 21, 1993
BARD URODYNAMIC CATHETER
FEN
Device, Cystometric, Hydraulic
365d
Cleared
Sep 13, 1993
AESCULAP TROCAR INSTRUMENT SET
GCS
Endoscope, Battery-powered And Accessories
74d
Cleared
Sep 09, 1993
KARL STORZ ENDOSCOPY-AMERICA, INC.
FFS
Image, Illumination, Fiberoptic, For Endoscope
135d
Cleared
Sep 03, 1993
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
FDX
Endoscopic Cytology Brush
221d
Cleared
Aug 27, 1993
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
344d
Cleared
Aug 20, 1993
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
140d
Cleared
Aug 18, 1993
THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
FGB
Ureteroscope And Accessories, Flexible/rigid
309d
Cleared
Jul 01, 1993
GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
GCS
Endoscope, Battery-powered And Accessories
107d
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