KASIOS TCP— 510(k) K042340

Substantially Equivalent

Kasios Biomaterials

FDA 510(k) clearance K042340 for KASIOS TCP, Substantially Equivalent on 2004-11-24. Applicant: Kasios Biomaterials.

Clearance details

Applicant: Kasios Biomaterials
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2004-08-30
Decision date: 2004-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.