DESARA MESH MODEL: CAL-DS01— 510(k) K101169

Substantially Equivalent

Caldera Medical, Inc.

FDA 510(k) clearance K101169 for DESARA MESH MODEL: CAL-DS01, Substantially Equivalent on 2010-05-20. Applicant: Caldera Medical, Inc..

Clearance details

Applicant: Caldera Medical, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2010-04-26
Decision date: 2010-05-20
Decision: Substantially Equivalent
Clearance type: Special
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.