FDA 510(k)

SurgTech Trauma System

K-Number: K161894 · 2017-02-21

Decision Date2017-02-21

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SurgTech Trauma System is a medical device manufactured by Surgtech, Inc.. It received FDA 510(k) clearance on 2017-02-21 under approval number K161894. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgTech Trauma System?

SurgTech Trauma System is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Surgtech, Inc.. The 510(k) number is K161894.

When was SurgTech Trauma System approved by the FDA?

SurgTech Trauma System received FDA 510(k) clearance on 2017-02-21, under approval number K161894.

What company makes SurgTech Trauma System?

SurgTech Trauma System is manufactured by Surgtech, Inc..

What is the FDA product code for SurgTech Trauma System?

The FDA product code for SurgTech Trauma System is HWC. This falls under the Cardiovascular category.

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Other Devices by Surgtech, Inc.

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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.