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FDA 510(k)

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

K-Number: K253989 · 2026-09-03

ApplicantMaxigen Biotech, Inc.
Decision Date2026-09-03
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) is the device name listed in this FDA 510(k) record. The listed applicant is Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K253989. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is 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)?

HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Maxigen Biotech, Inc.. The 510(k) number is K253989.

When did HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) receive FDA 510(k) clearance?

HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) received FDA 510(k) clearance on 2026-09-03, under 510(k) number K253989.

Who is the listed applicant 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)?

The FDA 510(k) record lists Maxigen Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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)?

The FDA product code 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) is NUC.

Other records listing Maxigen Biotech, Inc. as applicant

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Related Devices (Code: NUC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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