CLIP-ON SPACER 20%; 40%; 50%— 510(k) K041084

Substantially Equivalent

Serono, Inc.

FDA 510(k) clearance K041084 for CLIP-ON SPACER 20%; 40%; 50%, Substantially Equivalent on 2004-07-15. Applicant: Serono, Inc..

Clearance details

Applicant: Serono, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2004-04-26
Decision date: 2004-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.