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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K253989

510(k) cleared

HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)

Maxigen Biotech, Inc. · Sep 3, 2026 · K253989

FDA cleared the HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) from Maxigen Biotech, Inc. on Sep 3, 2026 under K253989, 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 Dec 12, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Maxigen Biotech, Inc. has one other decision in the tracker over the last 12 months: K242100 (SurgiAid Collagen Wound Dressing (HA)).

Questions & Answers

What did FDA clear under K253989?

K253989 is the FDA 510(k) for HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST), submitted by Maxigen Biotech, Inc.. FDA's decision date was Sep 3, 2026, under product code NUC (Lubricant, Personal).

Who makes the HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)?

Maxigen Biotech, Inc., based in Taoyuan, is the applicant of record for K253989.

How long did the K253989 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Sep 3, 2026, 265 days later.

← All decisions in September 2026

Sources