K213718

Substantially Equivalent

SOL-GUARD Safety Pull Button Collection Set

Applicant: Sol-Millennium Medical, Inc.
Product code: JKA
Advisory panel: Clinical Chemistry
Date received: 2021-11-24
Decision date: 2022-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwanee, GA, US

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.