SHOWER TROLLEY— 510(k) K841395

Substantially Equivalent

Setma, Inc.

FDA 510(k) clearance K841395 for SHOWER TROLLEY, Substantially Equivalent on 1984-05-07. Applicant: Setma, Inc..

Clearance details

Applicant: Setma, Inc.
Product code: Code FSA
Advisory panel: General Hospital
Date received: 1984-04-03
Decision date: 1984-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FSA

product code FSA

Death: 101
Injury: 767
Malfunction: 1,173
Other: 1
Total: 2,042

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.