ADHESIVE TAPE, WOUND CARE, WOUND DRESSING— 510(k) K854463

Name: FDA 510(k) clearance K854463
Creator: U.S. Food and Drug Administration
Published: 1986-03-03

Substantially Equivalent for Some Indications

Avery Intl.

FDA 510(k) clearance K854463 for ADHESIVE TAPE, WOUND CARE, WOUND DRESSING, Substantially Equivalent for Some Indications on 1986-03-03. Applicant: Avery Intl.. Device class: Unclassified.

Clearance details

Applicant: Avery Intl.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1985-11-06
Decision date: 1986-03-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Painesville, OH, US

Download summary PDF View on FDA.gov ↗

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K870021 — MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE1987-02-05
K870092 — MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM1987-02-05
K870093 — MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM1987-02-05
K870020 — IV SECUREMENT DEVICE1987-02-04
K870090 — IV SECUREMENT DEVICE USING HYTREL THERMO. FILM1987-02-04

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.