Cleared Traditional

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

K240708 · Suzhou Borage Medical Technology Co., Ltd. · Obstetrics & Gynecology

May 2024

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K240708 is an FDA 510(k) clearance for the Organic Cotton Tampon; Organic Cotton PESCVcord Tampon, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Suzhou Borage Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on May 10, 2024, 56 days after receiving the submission on March 15, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K240708 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2024
Decision Date	May 10, 2024
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.