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510(k) K920050

BIOLEX WOUND GEL, by Catalina Biomedical Corp. — Product Code MGQ

K920050 is an FDA 510(k) premarket notification submitted by Catalina Biomedical Corp. for the device "BIOLEX WOUND GEL,". The FDA issued a decision of SN on April 7, 1992. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Catalina Biomedical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 7, 1992
Date Received
January 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Catalina Biomedical Corp.

  • K913480 — WOUND CARE TRAY A (October 18, 1991)
  • K913479 — WOUND CARE TRAY B (October 8, 1991)
  • K896358 — VARI/MOIST WOUND DRESSING (February 1, 1990)
  • K896421 — TRANSPARENT FILM I.V. SITE/WOUND DRESSING (January 31, 1990)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)

FDA data resources