ODONTO-SCOPE— 510(k) K822562

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K822562 for ODONTO-SCOPE, Substantially Equivalent on 1982-10-06. Applicant: Treace Medical, Inc..

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code FSO
Advisory panel: General, Plastic Surgery
Date received: 1982-08-24
Decision date: 1982-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FSO

product code FSO

Other: 1
Total: 1

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.