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510(k) K945224

GRX FOAM DRESSING by Geritrex Corp. — Product Code KMF

K945224 is an FDA 510(k) premarket notification submitted by Geritrex Corp. for the device "GRX FOAM DRESSING". The FDA issued a decision of Substantially Equivalent on April 3, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Geritrex Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1995
Date Received
October 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Geritrex Corp.

  • K931509 — GERITREX STERILE SALINE SOLUTION FOR IRRIGATION (September 22, 1994)
  • K931511 — GERITREX STERILE WATER FOR IRRIGATION (February 14, 1994)
  • K931510 — GERITREX STERILE SALINE WET DRESSING (July 13, 1993)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources