Exsalta— 510(k) K221676

Substantially Equivalent

Drw Medical

FDA 510(k) clearance K221676 for Exsalta, Substantially Equivalent on 2022-09-16. Applicant: Drw Medical.

Clearance details

Applicant: Drw Medical
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2022-06-09
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aston, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.