Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack— 510(k) K191416

Substantially Equivalent

Caldera Medical, Inc.

FDA 510(k) clearance K191416 for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack, Substantially Equivalent on 2020-02-07. Applicant: Caldera Medical, Inc..

Clearance details

Applicant: Caldera Medical, Inc.
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2019-05-28
Decision date: 2020-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Agoura Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

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.