FDA.reportPublic FDA data

510(k) K900035

Device
WILSON-COOK COLON DECOMPRESSION SET
Applicant
WILSON-COOK MEDICAL, INC.
510(k) number
K900035
Product code
FEG  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-07
Date received
1990-01-02
Regulation
876.5980
Classification name
Tube, Double Lumen For Intestinal Decompression And/or Intubation
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
F MARSHALL
Address
4900 Bethania Station Rd. & 5951 Grassy Creek Blvd. Winston-Salem NC US 27105 27105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd.2017-08-01
K132314MEDLINE ANTI-REFLUX VALVEMedline Industries, Inc.2013-09-18
K053410GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTORKendall2006-01-06
K040388NEXT GENERATION SALEM SUMPKendall2004-05-17
K971354KNOTT NG TUBEMichael M. Knott, M.D.1997-11-19
K960176DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTERC.R. Bard, Inc.1996-07-24
K926073ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBESurgimark, Inc.1995-05-15
K935781ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAYSherwood Medical Co.1995-01-27
K921104LOPEZ VALVE WITH NG SUMP TUBEIcu Medical, Inc.1992-10-26
K880850KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVEKmb Medical Products Co.1988-05-26
K772282HODGE TUBEMallinckrodt Critical Care1978-03-09
K771048CATHETERS, DRAINAGEAxiom Medical, Inc.1977-07-19

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