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Daye Tampon

by Annes Daye, Ltd.

510(k) K223883

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 NumberK223883 Date18 Aug 2023ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 884.5470
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Daye Tampon is a menstrual tampon designed for the absorption of menstrual fluid. It is classified as an unscented menstrual tampon intended for internal use.

This device is regulated as a Class 2 medical device under regulation number 884.5470. It has received FDA 510(k) clearance.

Questions

AI-generated answers, 21 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 intended use of the Daye Tampon?

    The Daye Tampon is designed for the internal absorption of menstrual fluid during a menstrual cycle.

  • Is the Daye Tampon scented?

    No, the Daye Tampon is classified as an unscented menstrual tampon.

  • What is the regulatory status of this device?

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