DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK— 510(k) K904852

Name: FDA 510(k) clearance K904852
Creator: U.S. Food and Drug Administration
Published: 1991-01-25

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K904852 for DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK, Substantially Equivalent on 1991-01-25. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: Unclassified.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Product code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1990-10-29
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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K254168 — Actolind® (06.3637. Actolind® Gel Plus)2026-09-22
K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11

More clearances from Convatec, A Division of E.R. Squibb & Sons

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K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING2002-06-21
K990964 — SIGNADRESS DUODERM DRESSING1999-05-18
K984388 — HA ABSORBENT WOUND DRESSING1999-03-03
K980720 — NONWOVEN PAD1998-04-15
K980382 — NON-WOVEN COMPRESS1998-03-09

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.