FDA 510(k)

TissueTak device

K-Number: K203117 · 2021-01-07

Decision Date2021-01-07

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TissueTak device is the device name listed in this FDA 510(k) record. The listed applicant is Via Surgical , Ltd.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K203117. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TissueTak device?

TissueTak device is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K203117.

When did TissueTak device receive FDA 510(k) clearance?

TissueTak device received FDA 510(k) clearance on 2021-01-07, under 510(k) number K203117.

Who is the listed applicant for TissueTak device?

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

What is the FDA product code for TissueTak device?

The FDA product code for TissueTak device is GDW.

Other records listing Via Surgical , Ltd. 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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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.