DWFritz ASM2000— 510(k) K213894

Substantially Equivalent

Dwfritz Automation, Inc.

FDA 510(k) clearance K213894 for DWFritz ASM2000, Substantially Equivalent on 2022-03-14. Applicant: Dwfritz Automation, Inc..

Clearance details

Applicant: Dwfritz Automation, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-12-14
Decision date: 2022-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilsonville, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.