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FDA 510(k)

SafetyFix EasyOut System

K-Number: K180753 · 2018-04-20

ApplicantSafetyfix Medical Technologies, Inc.
Decision Date2018-04-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SafetyFix EasyOut System is the device name listed in this FDA 510(k) record. The listed applicant is Safetyfix Medical Technologies, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180753. 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 SafetyFix EasyOut System?

SafetyFix EasyOut System is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Safetyfix Medical Technologies, Inc.. The 510(k) number is K180753.

When did SafetyFix EasyOut System receive FDA 510(k) clearance?

SafetyFix EasyOut System received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180753.

Who is the listed applicant for SafetyFix EasyOut System?

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

What is the FDA product code for SafetyFix EasyOut System?

The FDA product code for SafetyFix EasyOut System is HWC. This falls under the Cardiovascular category.

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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