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FDA 510(k)

PUMA-G System

K-Number: K223916 · 2023-03-29

ApplicantCoaptech, Inc.
Decision Date2023-03-29
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PUMA-G System is a medical device manufactured by Coaptech, Inc.. It received FDA 510(k) clearance on 2023-03-29 under approval number K223916. 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 2023-03-29. It is manufactured by Coaptech, Inc.. The 510(k) number is K223916.

When was PUMA-G System approved by the FDA?

PUMA-G System received FDA 510(k) clearance on 2023-03-29, under approval number K223916.

What company makes PUMA-G System?

PUMA-G System is manufactured by Coaptech, Inc..

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

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

Other Devices by Coaptech, Inc.

K242211PUMA-G Pediatric System

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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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