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FDA 510(k)

CROMA Electrosurgical Generator (PRD-EMR-050)

K-Number: K242983 · 2025-02-05

ApplicantCreo Medical, Ltd.
Decision Date2025-02-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CROMA Electrosurgical Generator (PRD-EMR-050) is a medical device manufactured by Creo Medical, Ltd.. It received FDA 510(k) clearance on 2025-02-05 under approval number K242983. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROMA Electrosurgical Generator (PRD-EMR-050)?

CROMA Electrosurgical Generator (PRD-EMR-050) is a medical device that received FDA 510(k) clearance on 2025-02-05. It is manufactured by Creo Medical, Ltd.. The 510(k) number is K242983.

When was CROMA Electrosurgical Generator (PRD-EMR-050) approved by the FDA?

CROMA Electrosurgical Generator (PRD-EMR-050) received FDA 510(k) clearance on 2025-02-05, under approval number K242983.

What company makes CROMA Electrosurgical Generator (PRD-EMR-050)?

CROMA Electrosurgical Generator (PRD-EMR-050) is manufactured by Creo Medical, Ltd..

What is the FDA product code for CROMA Electrosurgical Generator (PRD-EMR-050)?

The FDA product code for CROMA Electrosurgical Generator (PRD-EMR-050) is GEI.

Related Clinical Trials

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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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