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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 / K261177

510(k) cleared

PINKSLIP Water-Based Personal Lubricant and Moisturizer

PINKSLIP, LLC · Jul 9, 2026 · K261177

FDA cleared the PINKSLIP Water-Based Personal Lubricant and Moisturizer from PINKSLIP, LLC on Jul 9, 2026 under K261177, a traditional 510(k). 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 Apr 10, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K261177?

K261177 is the FDA 510(k) for PINKSLIP Water-Based Personal Lubricant and Moisturizer, submitted by PINKSLIP, LLC. FDA's decision date was Jul 9, 2026, under product code NUC (Lubricant, Personal).

Who makes the PINKSLIP Water-Based Personal Lubricant and Moisturizer?

PINKSLIP, LLC, based in Whitefish, MT, is the applicant of record for K261177.

How long did the K261177 review take?

FDA received the submission on Apr 10, 2026 and issued its decision on Jul 9, 2026, 90 days later.

← All decisions in July 2026