Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Unscented Menstrual Tampon

K-Number: K222046 · 2022-09-30

ApplicantSuzhou Borage Medical Technology Co., Ltd.
Decision Date2022-09-30
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unscented Menstrual Tampon is a medical device manufactured by Suzhou Borage Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-30 under approval number K222046. 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 Tampon?

Unscented Menstrual Tampon is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Suzhou Borage Medical Technology Co., Ltd.. The 510(k) number is K222046.

When was Unscented Menstrual Tampon approved by the FDA?

Unscented Menstrual Tampon received FDA 510(k) clearance on 2022-09-30, under approval number K222046.

What company makes Unscented Menstrual Tampon?

Unscented Menstrual Tampon is manufactured by Suzhou Borage Medical Technology Co., Ltd..

What is the FDA product code for Unscented Menstrual Tampon?

The FDA product code for Unscented Menstrual Tampon is HEB.

Related Clinical Trials

NCT07561905 Tampon Safety-in-Use Study RECRUITING

Other Devices by Suzhou Borage Medical Technology Co., Ltd.

K240708Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

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.

↑