Exofin Precision Pen— 510(k) K212246

Name: FDA 510(k) clearance K212246
Creator: U.S. Food and Drug Administration
Published: 2021-09-09

Substantially Equivalent

Chemence Medical, Inc.

FDA 510(k) clearance K212246 for Exofin Precision Pen, Substantially Equivalent on 2021-09-09. Applicant: Chemence Medical, Inc.. Device class: 2.

Clearance details

Applicant: Chemence Medical, Inc.
Product code: Code MPN
Device class: Class 2
Regulation: 21 CFR 878.4010
Advisory panel: General, Plastic Surgery
Date received: 2021-07-19
Decision date: 2021-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

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.