STS SHIELD WITH MASK— 510(k) K961402

Substantially Equivalent

Innovative Outsourcing Solutions

FDA 510(k) clearance K961402 for STS SHIELD WITH MASK, Substantially Equivalent on 1996-07-12. Applicant: Innovative Outsourcing Solutions.

Clearance details

Applicant: Innovative Outsourcing Solutions
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1996-04-11
Decision date: 1996-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Chelmsford, MA, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.