Divine 9— 510(k) K150397

Substantially Equivalent

Carrashield Labs, Inc.

FDA 510(k) clearance K150397 for Divine 9, Substantially Equivalent on 2015-11-09. Applicant: Carrashield Labs, Inc..

Clearance details

Applicant: Carrashield Labs, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2015-02-18
Decision date: 2015-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

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.