FDA 510(k)

FasTouch Fixation System

K-Number: K162252 · 2016-11-14

Decision Date2016-11-14

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FasTouch Fixation System 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 2016-11-14 under 510(k) number K162252. 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 FasTouch Fixation System?

FasTouch Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-14. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K162252.

When did FasTouch Fixation System receive FDA 510(k) clearance?

FasTouch Fixation System received FDA 510(k) clearance on 2016-11-14, under 510(k) number K162252.

Who is the listed applicant for FasTouch Fixation System?

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 FasTouch Fixation System?

The FDA product code for FasTouch Fixation System 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.

K203117TissueTak device K181668FasTouch Absorbable Fixation System

Related Devices (Code: GDW)

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.