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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 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 2021-11-05 under 510(k) 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. The listed applicant is Unimax Medical Systems, Inc.. The 510(k) number is K211577.

When did SoftFix Balloon Trocar receive FDA 510(k) clearance?

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

Who is the listed applicant for SoftFix Balloon Trocar?

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 SoftFix Balloon Trocar?

The FDA product code for SoftFix Balloon Trocar 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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