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
2369 Gastroenterology & Urology devices
Cleared
Apr 30, 1991
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
FAD
Stent, Ureteral
279d
Cleared
Apr 25, 1991
BARD 3000 PLUS URETEROSCOPY SYSTEM
FGB
Ureteroscope And Accessories, Flexible/rigid
24d
Cleared
Apr 18, 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
85d
Cleared
Apr 16, 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
34d
Cleared
Apr 09, 1991
BARD(R) SYRINGE ASSIST IRRIGATION
OCX
Endoscopic Irrigation/suction System
147d
Cleared
Apr 02, 1991
BILIARY BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Mar 27, 1991
BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
FGH
Catheter, Double Lumen Female Urethrographic
70d
Cleared
Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
KNT
Tubes, Gastrointestinal (and Accessories)
53d
Cleared
Feb 13, 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
54d
Cleared
Jan 31, 1991
FLEXIFLO STOMATE EXTENSION TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
231d
Cleared
Jan 18, 1991
BUTTON REPLACEMENT GASTROSTOMY DEVICE
KGC
Tube, Gastro-enterostomy
88d
Cleared
Dec 10, 1990
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
FJI
Dialyzer, Capillary, Hollow Fiber
20d
Cleared
Nov 27, 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
111d
Cleared
Nov 21, 1990
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
KOD
Catheter, Urological
35d
Cleared
Nov 20, 1990
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
168d
Cleared
Nov 19, 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
117d
Cleared
Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
EZN
Dilator, Catheter, Ureteral
79d
Cleared
Aug 21, 1990
LEVEEN PERITINEO-VENOUS SHUNT
KPM
Shunt, Peritoneal
151d
Cleared
Aug 17, 1990
MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER
FAH
Dilator, Urethral, Mechanical
80d
Cleared
Aug 09, 1990
DOWD CATHETER
FAH
Dilator, Urethral, Mechanical
90d
Cleared
Jul 02, 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
KNT
Tubes, Gastrointestinal (and Accessories)
119d
Cleared
May 17, 1990
BARD SHORT RIGID URETEROSCOPE
FGB
Ureteroscope And Accessories, Flexible/rigid
85d
Cleared
May 02, 1990
DYNA-FLO URINARY DRAINAGE BAG
EYZ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
155d
Cleared
May 02, 1990
URINE COLLECTOR LEG BAG
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
155d
Cleared
Apr 19, 1990
SPS 550-IPS (INTEGRATED PATIENT STATION)
FIL
System, Dialysate Delivery, Single Pass
44d
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