FDA.reportPublic FDA data

510(k) K150243

Device
Invictus Medical GelShield
Applicant
Invictus Medical, Inc.
510(k) number
K150243
Product code
FMP  
Decision
Substantially Equivalent (SESE)
Decision date
2015-05-01
Date received
2015-02-02
Regulation
880.6450
Classification name
Protector, Skin Pressure
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chris Gilmer
Address
12500 Network Blvd., Suite 308 San Antonio TX US 78249 78249

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.1995-07-31
K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.1994-03-28
K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.1982-03-25
K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.1981-09-11
K811184SPENCO DERMAL PADSSpenco Medical Corp.1981-05-20
K802829SCANLAN VASCU-STATTScanlan Intl., Inc.1981-01-15
K802185ARTERIAL BLOOD SAMPLING KITCurrent Technologies, Inc.1980-10-10
K801694FLOTATION PAD FOR OPERATING TABLEAction Products, Inc.1980-08-27
K801195DERMALEX OR NATRAWOOL SKIN PRESSURE PROTStock Wild & Co.1980-06-09
K792297SPAN AIDS KITAmerican Hospital Supply Corp.1979-12-20
K791709HEEL/ELBOW PROTECTORSFibre Formations, Inc.1979-09-24
K790995CONTEXFoam Tek, Inc.1979-06-11
K781246FOAM COMFORT RINGSFibre Formations, Inc.1978-08-10
K780171ELBOW PROTECTORStat Medical Corp.1978-02-06
K772419HEEL OR ELBOW PROTECTORFred Sammons, Inc.1978-01-26

Legacy Summary#

summary

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