FEMMYCYCLE— 510(k) K121857

Name: FDA 510(k) clearance K121857
Creator: U.S. Food and Drug Administration
Published: 2012-11-15

Substantially Equivalent

Femcap Incorporated

FDA 510(k) clearance K121857 for FEMMYCYCLE, Substantially Equivalent on 2012-11-15. Applicant: Femcap Incorporated. Device class: 2.

Clearance details

Applicant: Femcap Incorporated
Product code: Code HHE
Device class: Class 2
Regulation: 21 CFR 884.5400
Advisory panel: Obstetrics/Gynecology
Date received: 2012-06-26
Decision date: 2012-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, 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.