RUMBLE TUFF— 510(k) K113315

Substantially Equivalent

Acute Ideas Co. , Ltd.

FDA 510(k) clearance K113315 for RUMBLE TUFF, Substantially Equivalent on 2012-11-20. Applicant: Acute Ideas Co. , Ltd..

Clearance details

Applicant: Acute Ideas Co. , Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2011-11-09
Decision date: 2012-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orem, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.