DESARA MESH, DESARA BLUE— 510(k) K132069

Substantially Equivalent

Caldera Medical, Inc.

FDA 510(k) clearance K132069 for DESARA MESH, DESARA BLUE, Substantially Equivalent on 2013-09-23. Applicant: Caldera Medical, Inc..

Clearance details

Applicant: Caldera Medical, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2013-07-03
Decision date: 2013-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Agoura Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.