BIOLEX WOUND GEL,— 510(k) K920050

Name: FDA 510(k) clearance K920050
Creator: U.S. Food and Drug Administration
Published: 1992-04-07

Substantially Equivalent for Some Indications

Catalina Biomedical Corp.

FDA 510(k) clearance K920050 for BIOLEX WOUND GEL,, Substantially Equivalent for Some Indications on 1992-04-07. Applicant: Catalina Biomedical Corp.. Device class: Unclassified.

Clearance details

Applicant: Catalina Biomedical Corp.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1992-01-06
Decision date: 1992-04-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Duarte, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MGQ

view all

K171879 — HylaGuard Moisturizing Cream2017-10-16
K083024 — HYLATOPIC EMOLLIENT FOAM2009-03-27
K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION2005-07-19
K041268 — SILVERSITE OR CALGITROL2004-09-20
K040019 — SILVERSEAL2004-07-23

More clearances from Catalina Biomedical Corp.

view all

K913480 — WOUND CARE TRAY A1991-10-18
K913479 — WOUND CARE TRAY B1991-10-08
K896358 — VARI/MOIST WOUND DRESSING1990-02-01
K896421 — TRANSPARENT FILM I.V. SITE/WOUND DRESSING1990-01-31

Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.