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
8444 Gastroenterology & Urology devices
Cleared
Dec 18, 1997
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
FFK
Lithotriptor, Electro-hydraulic
43d
Cleared
Dec 18, 1997
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
OCT
Anti Fog Solution And Accessories, Endoscopy
23d
Cleared
Dec 15, 1997
COURIER ST BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
124d
Cleared
Dec 11, 1997
CRIT-LINE MONITOR (CLMIII)
MQS
System, Hemodialysis, Access Recirculation Monitoring
163d
Cleared
Dec 11, 1997
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
128d
Cleared
Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
FBO
Cystourethroscope
122d
Cleared
Dec 09, 1997
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER
KNW
Instrument, Biopsy
159d
Cleared
Dec 09, 1997
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
KNW
Instrument, Biopsy
36d
Cleared
Dec 05, 1997
SPHINCTEROTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
59d
Cleared
Dec 03, 1997
S-357 VIDEO IMAGING SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
58d
Cleared
Dec 02, 1997
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
FCL
Forceps, Biopsy, Non-electric
71d
Cleared
Dec 01, 1997
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
OCW
Endoscopic Tissue Approximation Device
89d
Cleared
Dec 01, 1997
THE AUTO SUTURE* MIBB** SYSTEM
KNW
Instrument, Biopsy
77d
Cleared
Nov 26, 1997
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
FIP
Subsystem, Water Purification
379d
Cleared
Nov 26, 1997
BODYSTAT
MNW
Analyzer, Body Composition
210d
Cleared
Nov 26, 1997
BELZER-MPS
KDN
System, Perfusion, Kidney
176d
Cleared
Nov 26, 1997
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
KOC
Accessories, Blood Circuit, Hemodialysis
168d
Cleared
Nov 26, 1997
COBRA HAND PIECE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
79d
Cleared
Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
419d
Cleared
Nov 24, 1997
WILSON-COOK STRICTURE MEASURING CATHETER
ODD
Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
90d
Cleared
Nov 24, 1997
KARL STORZ DIRECT COUPLED CAMERA HEAD
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
87d
Cleared
Nov 21, 1997
URESIL GUIDEWIRE
FGE
Stents, Drains And Dilators For The Biliary Ducts
134d
Cleared
Nov 19, 1997
G.E.M. WATER SYSTEMS, INTERNATIONAL
FIN
Tank, Holding, Dialysis
268d
Cleared
Nov 19, 1997
KNOTT NG TUBE
FEG
Tube, Double Lumen For Intestinal Decompression And/or Intubation
222d
Cleared
Nov 14, 1997
RESTORE (A.K.A. CAPSURE)
MNG
External Urethral Occluder, Urinary Incontinence-control, Female
217d
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