K243421
- 510(k) number
- K243421
- Device name
- Lelo Hex Lubricated Natural Rubber Latex Condom
- Applicant
- Lelo, Inc. CA · US
- Product code
- HIS — Condom
- Decision date
- 2025-03-07
- Date received
- 2024-11-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243421.pdf
Official FDA record: K243421
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.