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FDA 510(k)

SoftFix Balloon Trocar

K-Number: K211577 · 2021-11-05

ApplicantUnimax Medical Systems, Inc.
Decision Date2021-11-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SoftFix Balloon Trocar is a medical device manufactured by Unimax Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-11-05 under approval number K211577. 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 SoftFix Balloon Trocar?

SoftFix Balloon Trocar is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Unimax Medical Systems, Inc.. The 510(k) number is K211577.

When was SoftFix Balloon Trocar approved by the FDA?

SoftFix Balloon Trocar received FDA 510(k) clearance on 2021-11-05, under approval number K211577.

What company makes SoftFix Balloon Trocar?

SoftFix Balloon Trocar is manufactured by Unimax Medical Systems, Inc..

What is the FDA product code for SoftFix Balloon Trocar?

The FDA product code for SoftFix Balloon Trocar is GCJ.

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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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