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FDA 510(k)

Vario-Cup System

K-Number: K221794 · 2022-07-20

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2022-07-20
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vario-Cup System is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K221794. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vario-Cup System?

Vario-Cup System is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K221794.

When did Vario-Cup System receive FDA 510(k) clearance?

Vario-Cup System received FDA 510(k) clearance on 2022-07-20, under 510(k) number K221794.

Who is the listed applicant for Vario-Cup System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vario-Cup System?

The FDA product code for Vario-Cup System is KWY.

Other records listing Waldemar Link GmbH & Co. KG as applicant

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: KWY)

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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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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