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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5376 Gastroenterology & Urology devices
Cleared
May 29, 1987
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
FJI
Dialyzer, Capillary, Hollow Fiber
63d
Cleared
May 18, 1987
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
LNK
Laser For Gastro-urology Use
63d
Cleared
May 18, 1987
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
LNK
Laser For Gastro-urology Use
63d
Cleared
May 18, 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
FKO
Catheter, Peritoneal Dialysis, Single Use
13d
Cleared
May 15, 1987
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
LNK
Laser For Gastro-urology Use
60d
Cleared
May 15, 1987
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
LNK
Laser For Gastro-urology Use
60d
Cleared
May 15, 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
57d
Cleared
May 11, 1987
SINGLE LUMEN ACUTE CATHETER
LFJ
Catheter, Subclavian
103d
Cleared
Apr 30, 1987
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
37d
Cleared
Apr 30, 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
FKP
System, Dialysate Delivery, Single Patient
34d
Cleared
Apr 29, 1987
10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE
MPB
Catheter, Hemodialysis, Non-implanted
23d
Cleared
Apr 17, 1987
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
57d
Cleared
Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
24d
Cleared
Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
24d
Cleared
Apr 10, 1987
KADIR HI-TORQUE GUIDE WIRE
KOD
Catheter, Urological
10d
Cleared
Apr 06, 1987
CAPILLARY FLOW DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
82d
Cleared
Apr 01, 1987
(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
62d
Cleared
Apr 01, 1987
NORTA (TM) UROBAG
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
56d
Cleared
Apr 01, 1987
SOFT TISSUE BIOPSY NEEDLE
KNW
Instrument, Biopsy
34d
Cleared
Apr 01, 1987
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
KOD
Catheter, Urological
22d
Cleared
Mar 30, 1987
VAN-TEC PUMPING SYSTEM
KOD
Catheter, Urological
48d
Cleared
Mar 30, 1987
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
FBO
Cystourethroscope
39d
Cleared
Mar 30, 1987
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
FFL
Dislodger, Stone, Basket, Ureteral, Metal
39d
Cleared
Mar 27, 1987
CAPILLARY FLOW HOLLOW FIBER DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
228d
Cleared
Mar 27, 1987
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
108d
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