MICROMYST APPLICATOR, MODEL 20-5000— 510(k) K082454

Substantially Equivalent

Covidien

FDA 510(k) clearance K082454 for MICROMYST APPLICATOR, MODEL 20-5000, Substantially Equivalent on 2008-11-07. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2008-08-26
Decision date: 2008-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.