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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 a medical device manufactured by Cycle, LLC. It received FDA 510(k) clearance on 2021-08-13 under approval 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. It is manufactured by Cycle, LLC. The 510(k) number is K211519.

When was Every Cycle Reusable Tampon Applicator approved by the FDA?

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

What company makes Every Cycle Reusable Tampon Applicator?

Every Cycle Reusable Tampon Applicator is manufactured by Cycle, LLC.

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

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

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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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