FDA.reportPublic FDA data

510(k) K890096

Device
BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
Applicant
MEDICAL INVENTORS CORP., INC.
510(k) number
K890096
Product code
FCN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-07-14
Date received
1989-01-10
Regulation
876.5250
Classification name
Urinary Drainage Collection Kit, For Indwelling Catheter
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROLAND C ZAGNOLI
Address
7575 Dr. Phillips Blvd., Suite #310 Orlando FL US 32819 32819

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.1995-06-15
K945258CATCO URINARY COLLECTION KITCatco Medical, Inc.1995-02-16
K915166MICROCYCLERMedical Inventors Corp., Inc.1994-09-07
K922346FEMALE URINE SAMPLING DEVICEMentor Corp.1992-08-14
K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.1988-12-19
K883610LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.1988-10-12
K780134URINARY DRAINAGE MONITORING SYSTEMMedical Devices, Inc.1978-02-02
K772133URINE SPECIMEN COLLECTING DEVICEKendall Research Center1977-11-28
K771210UROGARD URINARY DRAINAGE BAGTerumo America, Inc.1977-07-11

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases