Plum Vagiceuticals Vaginal Moisturizing Suppositories— 510(k) K261909
Substantially EquivalentPCCA, Inc.
FDA 510(k) clearance K261909 for Plum Vagiceuticals Vaginal Moisturizing Suppositories, Substantially Equivalent on 2026-07-06. Applicant: PCCA, Inc.. Device class: 2.
Summary
PCCA's Plum Vagiceuticals Vaginal Moisturizing Suppositories are filed under NUC, personal lubricants. The device name describes suppositories, which the code name doesn't mention, and the record gives no formulation.
Class II, 21 CFR 884.5300. Obstetrics and Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
PCCA filed from Houston, Texas. Review took 28 calendar days (June 8 to July 6, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- PCCA, Inc.
- Product code
- Product code NUC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code NUC
view allMore clearances from PCCA, Inc.
view allAdverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . 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.