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FDA 510(k)

LiVac Retractor System

K-Number: K162445 · 2016-10-20

ApplicantLivac Pty, Ltd.
Decision Date2016-10-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LiVac Retractor System is the device name listed in this FDA 510(k) record. The listed applicant is Livac Pty, Ltd.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K162445. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiVac Retractor System?

LiVac Retractor System is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Livac Pty, Ltd.. The 510(k) number is K162445.

When did LiVac Retractor System receive FDA 510(k) clearance?

LiVac Retractor System received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162445.

Who is the listed applicant for LiVac Retractor System?

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

What is the FDA product code for LiVac Retractor System?

The FDA product code for LiVac Retractor System is GCJ.

Related Devices (Code: GCJ)

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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