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FDA 510(k)

Every Cycle Reusable Tampon Applicator

K-Number: K211519 · 2021-08-13

ApplicantCycle, LLC
Decision Date2021-08-13
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Every Cycle Reusable Tampon Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Cycle, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211519. 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 Every Cycle Reusable Tampon Applicator?

Every Cycle Reusable Tampon Applicator is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Cycle, LLC. The 510(k) number is K211519.

When did Every Cycle Reusable Tampon Applicator receive FDA 510(k) clearance?

Every Cycle Reusable Tampon Applicator received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211519.

Who is the listed applicant for Every Cycle Reusable Tampon Applicator?

The FDA 510(k) record lists Cycle, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Every Cycle Reusable Tampon Applicator?

The FDA product code for Every Cycle Reusable Tampon Applicator is HEB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.

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.

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