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FDA 510(k)

PUMA-G Pediatric System

K-Number: K242211 · 2025-04-29

ApplicantCoaptech, Inc.
Decision Date2025-04-29
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PUMA-G Pediatric System is a medical device manufactured by Coaptech, Inc.. It received FDA 510(k) clearance on 2025-04-29 under approval number K242211. 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 Pediatric System?

PUMA-G Pediatric System is a medical device that received FDA 510(k) clearance on 2025-04-29. It is manufactured by Coaptech, Inc.. The 510(k) number is K242211.

When was PUMA-G Pediatric System approved by the FDA?

PUMA-G Pediatric System received FDA 510(k) clearance on 2025-04-29, under approval number K242211.

What company makes PUMA-G Pediatric System?

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

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

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

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Related PubMed Literature

PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Coaptech, Inc.

K223916PUMA-G System

Related Devices (Code: 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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