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510(k) K150243

Invictus Medical GelShield by Invictus Medical, Inc. — Product Code FMP

K150243 is an FDA 510(k) premarket notification submitted by Invictus Medical, Inc. for the device "Invictus Medical GelShield". The FDA issued a decision of Substantially Equivalent on May 1, 2015. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Invictus Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2015
Date Received
February 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Skin Pressure
Device Class
Class I
Regulation Number
880.6450
Review Panel
HO
Submission Type

Other clearances by Invictus Medical, Inc.

Other clearances for product code FMP

  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K820584 — DECUBICARE PADS & ACCESSORIES (March 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (September 11, 1981)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K802829 — SCANLAN VASCU-STATT (January 15, 1981)
  • K802185 — ARTERIAL BLOOD SAMPLING KIT (October 10, 1980)
  • K801694 — FLOTATION PAD FOR OPERATING TABLE (August 27, 1980)
  • K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (June 9, 1980)
  • K792297 — SPAN AIDS KIT (December 20, 1979)

FDA data resources