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Tampon, Untreated

by Hygieia Healthcare, Ltd. 2 variants

510(k) K912941

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912941 Date6 Mar 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HEB
FDA applicant
Hygieia Healthcare , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.5470
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tampon, Untreated is a menstrual device consisting of a plug made of cellulosic or synthetic material. It is designed to be inserted into the vagina to absorb menstrual or other vaginal discharge.

This device is regulated as a class 2 medical device under regulation number 884.5470. It received FDA 510(k) clearance under the traditional submission process.

Other devices from Hygieia Healthcare, Ltd.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Tampon, Untreated?

    This device is designed to be inserted into the vagina specifically to absorb menstrual flow or other types of vaginal discharge.

  • What materials are used to construct this tampon?

    The device consists of a plug manufactured from either cellulosic or synthetic materials, which are chosen for their absorbent properties.

  • How is this device classified for regulatory purposes?

    The Tampon, Untreated is regulated as a class 2 medical device under regulation number 884.5470 and has received FDA 510(k) clearance.