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FDA 510(k)

PUMA-G System

K-Number: K183057 · 2019-04-10

ApplicantCoaptech, LLC
Decision Date2019-04-10
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PUMA-G System is a medical device manufactured by Coaptech, LLC. It received FDA 510(k) clearance on 2019-04-10 under approval number K183057. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUMA-G System?

PUMA-G System is a medical device that received FDA 510(k) clearance on 2019-04-10. It is manufactured by Coaptech, LLC. The 510(k) number is K183057.

When was PUMA-G System approved by the FDA?

PUMA-G System received FDA 510(k) clearance on 2019-04-10, under approval number K183057.

What company makes PUMA-G System?

PUMA-G System is manufactured by Coaptech, LLC.

What is the FDA product code for PUMA-G System?

The FDA product code for PUMA-G System is KGC.

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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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