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
2362 Gastroenterology & Urology devices
Cleared
Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
FBO
Cystourethroscope
122d
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 05, 1997
SPHINCTEROTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
59d
Cleared
Dec 01, 1997
THE AUTO SUTURE* MIBB** SYSTEM
KNW
Instrument, Biopsy
77d
Cleared
Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
419d
Cleared
Nov 12, 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
MSE
Hemodialyzer, Re-use, Low Flux
264d
Cleared
Nov 12, 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
MSE
Hemodialyzer, Re-use, Low Flux
264d
Cleared
Nov 10, 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
82d
Cleared
Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
494d
Cleared
Oct 16, 1997
BARD ENDOSCOPIC OVERTUBE (#000307)
FED
Endoscopic Access Overtube, Gastroenterology-urology
30d
Cleared
Oct 16, 1997
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
MND
Ligator, Esophageal
202d
Cleared
Oct 09, 1997
CRE BALLOON DILATATION CATHETER
KNQ
Dilator, Esophageal
182d
Cleared
Oct 08, 1997
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
61d
Cleared
Oct 07, 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
83d
Cleared
Sep 09, 1997
BLOOD MONITOR PUMP
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
203d
Cleared
Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
FPD
Tube, Feeding
89d
Cleared
Aug 12, 1997
KARL STORZ MODEL 203020 20 EQUIMAT
LJH
System, Irrigation, Urological
75d
Cleared
Aug 12, 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
75d
Cleared
Jul 24, 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
115d
Cleared
Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
189d
Cleared
Jun 20, 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
210d
Cleared
Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
LJH
System, Irrigation, Urological
88d
Cleared
May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
275d
Cleared
May 20, 1997
ULTRAFLEX DIAMOND
FGE
Stents, Drains And Dilators For The Biliary Ducts
299d
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