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
154d
Avg (2y)
1976
Since
2656 Gastroenterology & Urology devices
Cleared
Aug 07, 1991
FLEXIFLO ENTERAL FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
190d
Cleared
Aug 07, 1991
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
180d
Cleared
Aug 07, 1991
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
85d
Cleared
Jul 24, 1991
BARD REPLACEMENT GASTROSTOMY TUBE
KGC
Tube, Gastro-enterostomy
169d
Cleared
Jun 20, 1991
BIPROBE(TM)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
10d
Cleared
Jun 10, 1991
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
FCG
Biopsy Needle
110d
Cleared
May 30, 1991
BARD SINGULAR BIOPSY FORCEPS
FCL
Forceps, Biopsy, Non-electric
10d
Cleared
May 28, 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
KOC
Accessories, Blood Circuit, Hemodialysis
77d
Cleared
May 28, 1991
BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE
FOC
Bag, Urine Collection, Newborn
63d
Cleared
May 06, 1991
TOUCHLESS II INTERMITTENT CATHETER
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
81d
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 19, 1991
ARGYLE POLYURETHANE SALEM SUMP TUBE
BSS
Tube, Nasogastric
72d
Cleared
Apr 18, 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
85d
Cleared
Apr 16, 1991
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
55d
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
CHF-B20 CHOLEDOCHOSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
154d
Cleared
Mar 27, 1991
SIF-SW
FDA
Enteroscope And Accessories
154d
Cleared
Mar 27, 1991
BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
FGH
Catheter, Double Lumen Female Urethrographic
70d
Cleared
Mar 21, 1991
IE MAGNETIC EXTRACTOR
FCC
Endoscopic Magnetic Retriever
157d
Cleared
Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
KNT
Tubes, Gastrointestinal (and Accessories)
53d
Cleared
Mar 15, 1991
BALLOON CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
151d
Cleared
Feb 13, 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
FGE
Stents, Drains And Dilators For The Biliary Ducts
54d
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