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FDA 510(k)

UNIMAX TROCAR SYSTEM

K-Number: K112358 · 2011-10-17

ApplicantUnimax Medical Systems, Inc.
Decision Date2011-10-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNIMAX TROCAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Unimax Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-10-17 under 510(k) number K112358. 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 UNIMAX TROCAR SYSTEM?

UNIMAX TROCAR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is Unimax Medical Systems, Inc.. The 510(k) number is K112358.

When did UNIMAX TROCAR SYSTEM receive FDA 510(k) clearance?

UNIMAX TROCAR SYSTEM received FDA 510(k) clearance on 2011-10-17, under 510(k) number K112358.

Who is the listed applicant for UNIMAX TROCAR SYSTEM?

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

What is the FDA product code for UNIMAX TROCAR SYSTEM?

The FDA product code for UNIMAX TROCAR SYSTEM is GCJ.

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Other records listing Unimax Medical Systems, Inc. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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