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FDA 510(k)

SurgTech Trauma System

K-Number: K161894 · 2017-02-21

ApplicantSurgtech, Inc.
Decision Date2017-02-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech Trauma System is the device name listed in this FDA 510(k) record. The listed applicant is Surgtech, Inc.. It received FDA 510(k) clearance on 2017-02-21 under 510(k) 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. The listed applicant is Surgtech, Inc.. The 510(k) number is K161894.

When did SurgTech Trauma System receive FDA 510(k) clearance?

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

Who is the listed applicant for SurgTech Trauma System?

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

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.

Other records listing Surgtech, Inc. 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: HWC)

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.

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