FDA 510(k)

GM Implant Tubes, Length Cutting Gauge

K-Number: K172533 · 2018-10-22

Decision Date2018-10-22

Product CodeJAQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GM Implant Tubes, Length Cutting Gauge is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-10-22 under 510(k) number K172533. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM Implant Tubes, Length Cutting Gauge?

GM Implant Tubes, Length Cutting Gauge is a medical device that received FDA 510(k) clearance on 2018-10-22. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K172533.

When did GM Implant Tubes, Length Cutting Gauge receive FDA 510(k) clearance?

GM Implant Tubes, Length Cutting Gauge received FDA 510(k) clearance on 2018-10-22, under 510(k) number K172533.

Who is the listed applicant for GM Implant Tubes, Length Cutting Gauge?

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

What is the FDA product code for GM Implant Tubes, Length Cutting Gauge?

The FDA product code for GM Implant Tubes, Length Cutting Gauge is JAQ.

Other records listing Varian Medical Systems, Inc. as applicant

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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.