ASCEND— 510(k) K083722

Substantially Equivalent

Caldera Medical, Inc.

FDA 510(k) clearance K083722 for ASCEND, Substantially Equivalent on 2009-03-31. Applicant: Caldera Medical, Inc..

Clearance details

Applicant: Caldera Medical, Inc.
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2008-12-15
Decision date: 2009-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Agoura Hills, CA, US

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Adverse events under product code OTP

product code OTP

Injury: 1,061
Total: 1,061

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.