SAGE 2200 STERILE SPECIMEN CONTAINER— 510(k) K813408

Substantially Equivalent

Sage Products, Inc.

FDA 510(k) clearance K813408 for SAGE 2200 STERILE SPECIMEN CONTAINER, Substantially Equivalent on 1982-01-25. Applicant: Sage Products, Inc..

Clearance details

Applicant: Sage Products, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1981-12-07
Decision date: 1982-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.