ROKI Surgical Mask— 510(k) K214094

Substantially Equivalent

Roki Co., Ltd.

FDA 510(k) clearance K214094 for ROKI Surgical Mask, Substantially Equivalent on 2022-02-24. Applicant: Roki Co., Ltd..

Clearance details

Applicant: Roki Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-12-28
Decision date: 2022-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamamatsu-Shi, JP

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.