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FDA 510(k)

General & Plastic Surgery Instruments

K-Number: K152400 · 2016-01-22

ApplicantSontec Instruments, Inc.
Decision Date2016-01-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

General & Plastic Surgery Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Sontec Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152400. 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 General & Plastic Surgery Instruments?

General & Plastic Surgery Instruments is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Sontec Instruments, Inc.. The 510(k) number is K152400.

When did General & Plastic Surgery Instruments receive FDA 510(k) clearance?

General & Plastic Surgery Instruments received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152400.

Who is the listed applicant for General & Plastic Surgery Instruments?

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

What is the FDA product code for General & Plastic Surgery Instruments?

The FDA product code for General & Plastic Surgery Instruments 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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