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Callaly Tampliner

by Calla Lily Personal Care, Ltd. 2 variants

510(k) K211469

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 · Special NumberK211469 Date10 Jun 2021ClearedStatusActive

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  • Withdrawn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, 24 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 Callaly Tampliner is a tampon, menstrual, unscented device designed to absorb menstrual fluid. It is classified as a Class II medical device under product code HEB and regulation number 884.5470.

The device is inserted into the vagina for use during menstruation. It is supplied as a single-use product and has received FDA 510(k) clearance under K211469, determined to be substantially equivalent to a predicate device. The manufacturer is Calla Lily Personal Care, Ltd., based in London, GB.

Other devices from Calla Lily Personal Care, Ltd.

Questions

AI-generated answers, 24 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 Callaly Tampliner used for?

    The Callaly Tampliner is designed to absorb menstrual fluid during menstruation. It is inserted into the vagina for this purpose, as stated in the device description.

  • Is the Callaly Tampliner reusable or single-use?

    The Callaly Tampliner is supplied as a single-use product, meaning it is intended for one-time use only and should be disposed of after each use.

  • What regulatory clearance does the Callaly Tampliner have?

    The Callaly Tampliner has received FDA 510(k) clearance under K211469, which determined it to be substantially equivalent to a predicate device.

  • Who manufactures the Callaly Tampliner and where are they based?

    The Callaly Tampliner is manufactured by Calla Lily Personal Care, Ltd., which is based in London, United Kingdom (GB).