RHEA CUP— 510(k) K112165

Name: FDA 510(k) clearance K112165
Creator: U.S. Food and Drug Administration
Published: 2012-05-24

Substantially Equivalent

Apex Medical Technologies, Inc.

FDA 510(k) clearance K112165 for RHEA CUP, Substantially Equivalent on 2012-05-24. Applicant: Apex Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Apex Medical Technologies, Inc.
Product code: Code HHE
Device class: Class 2
Regulation: 21 CFR 884.5400
Advisory panel: Obstetrics/Gynecology
Date received: 2011-07-28
Decision date: 2012-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HHE

product code HHE

Injury: 344
Total: 344

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.