SWEEN UNIVERSAL BED RAIL PADS— 510(k) K810846

Substantially Equivalent

Sween Corp.

FDA 510(k) clearance K810846 for SWEEN UNIVERSAL BED RAIL PADS, Substantially Equivalent on 1981-04-17. Applicant: Sween Corp..

Clearance details

Applicant: Sween Corp.
Product code: Code FNJ
Advisory panel: General Hospital
Date received: 1981-03-27
Decision date: 1981-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.