MSC

Barrier, Std, Oral Sex

Product code
MSC
Device name
Barrier, Std, Oral Sex
Device class
Class 2
21 CFR
21 CFR 884.5300
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-14.

NumberDecision dateApplicantDevice nameSummary
K2536622026-07-14Luwi, LLCLIXI (LXOSFM1)PDF

1 summaries are archived here for direct download.

Official FDA classification page: MSC
Classification and pathway per current FDA publications. Data from openFDA (CC0).