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FDA 510(k)

VariLymph 12 pro

K-Number: K193476 · 2020-08-19

ApplicantSlk Medical GmbH
Decision Date2020-08-19
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VariLymph 12 pro is the device name listed in this FDA 510(k) record. The listed applicant is Slk Medical GmbH. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K193476. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VariLymph 12 pro?

VariLymph 12 pro is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Slk Medical GmbH. The 510(k) number is K193476.

When did VariLymph 12 pro receive FDA 510(k) clearance?

VariLymph 12 pro received FDA 510(k) clearance on 2020-08-19, under 510(k) number K193476.

Who is the listed applicant for VariLymph 12 pro?

The FDA 510(k) record lists Slk Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VariLymph 12 pro?

The FDA product code for VariLymph 12 pro is JOW.

Other records listing Slk Medical GmbH 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.

K210913V12 PRO

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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