Aspiron S ACP System— 510(k) K220147

Substantially Equivalent

U&I Corporation

FDA 510(k) clearance K220147 for Aspiron S ACP System, Substantially Equivalent on 2022-02-16. Applicant: U&I Corporation.

Clearance details

Applicant: U&I Corporation
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2022-01-19
Decision date: 2022-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Uijeongbu-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.