BOUNDARY TUBING HOLDERS— 510(k) K810888

Substantially Equivalent

The Buckeye Cellulose Corp.

FDA 510(k) clearance K810888 for BOUNDARY TUBING HOLDERS, Substantially Equivalent on 1981-04-23. Applicant: The Buckeye Cellulose Corp..

Clearance details

Applicant: The Buckeye Cellulose Corp.
Product code: Code FZX
Advisory panel: General, Plastic Surgery
Date received: 1981-04-02
Decision date: 1981-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.