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FDA 510(k)

Unscented menstrual three-piece applicator tampon

K-Number: K252613 · 2025-09-19

ApplicantUnibeauty (Hubei) Technology Co., Ltd.
Decision Date2025-09-19
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unscented menstrual three-piece applicator tampon is a medical device manufactured by Unibeauty (Hubei) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under approval number K252613. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unscented menstrual three-piece applicator tampon?

Unscented menstrual three-piece applicator tampon is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Unibeauty (Hubei) Technology Co., Ltd.. The 510(k) number is K252613.

When was Unscented menstrual three-piece applicator tampon approved by the FDA?

Unscented menstrual three-piece applicator tampon received FDA 510(k) clearance on 2025-09-19, under approval number K252613.

What company makes Unscented menstrual three-piece applicator tampon?

Unscented menstrual three-piece applicator tampon is manufactured by Unibeauty (Hubei) Technology Co., Ltd..

What is the FDA product code for Unscented menstrual three-piece applicator tampon?

The FDA product code for Unscented menstrual three-piece applicator tampon is HEB.

Related Clinical Trials

NCT07561905 Tampon Safety-in-Use Study RECRUITING NCT07521553 TENS for Primary Dysmenorrhea COMPLETED NCT07394777 An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis COMPLETED NCT07326722 Delivering tAN to Reduce HMB: The LUNA Study RECRUITING NCT07501429 Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury RECRUITING

Other Devices by Unibeauty (Hubei) Technology Co., Ltd.

K232598Unscented Menstrual Tampon K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

Related Devices (Code: HEB)

K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super PlFirst Quality Hygienic, Inc. K172118U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation K162746Ontex and other proprietary namesOntex Bvba K181911Interlude 100% Cotton TamponAlbaad Fem K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem

Official Source

View on FDA Database →

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

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