AMSure® Single Use Saline Topical Solution— 510(k) K201138

Substantially Equivalent

Amsino Medical, Inc.

FDA 510(k) clearance K201138 for AMSure® Single Use Saline Topical Solution, Substantially Equivalent on 2021-04-14. Applicant: Amsino Medical, Inc..

Clearance details

Applicant: Amsino Medical, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2020-04-28
Decision date: 2021-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.