510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150243Substantially Equivalent

Invictus Medical GelShield

Invictus Medical, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150243 is the FDA 510(k) clearance record for Invictus Medical GelShield, a class I device, cleared for Invictus Medical, Inc. on under FDA product code FMP (Protector, Skin Pressure). FDA records list 2 510(k) clearances for Invictus Medical, Inc., from to . As of , FDA records show no recalls naming K150243.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FMP Protector, Skin Pressure
Regulation
21 CFR 880.6450
Device class
Class I
Review panel
General Hospital
Applicant
Invictus Medical, Inc. 12500 Network Blvd., Suite 308, San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMP

Trailing 12 months

FDA records hold no clearances under product code FMP in the trailing twelve months.

FDA records show no clearances under product code FMP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260