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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261909

510(k) cleared

Plum Vagiceuticals Vaginal Moisturizing Suppositories

PCCA, Inc. · Jul 6, 2026 · K261909

FDA cleared the Plum Vagiceuticals Vaginal Moisturizing Suppositories from PCCA, Inc. on Jul 6, 2026 under K261909, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 8, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for PCCA, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261909?

K261909 is the FDA 510(k) for Plum Vagiceuticals Vaginal Moisturizing Suppositories, submitted by PCCA, Inc.. FDA's decision date was Jul 6, 2026, under product code NUC (Lubricant, Personal).

Who makes the Plum Vagiceuticals Vaginal Moisturizing Suppositories?

PCCA, Inc., based in Houston, TX, is the applicant of record for K261909.

How long did the K261909 review take?

FDA received the submission on Jun 8, 2026 and issued its decision on Jul 6, 2026, 28 days later.

← All decisions in July 2026