SCOUT BX Delivery System— 510(k) K212882

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K212882 for SCOUT BX Delivery System, Substantially Equivalent on 2022-04-08. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2021-09-10
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.