Croma Generator

FDA UDIEUDAMED

Class II (US FDA UDI)

by Creo Medical, Ltd.

Identity

Trade Name: Croma Generator FDA UDI
Generic Name: Microwave/electrosurgical system generator FDA UDI
Device Name: A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery. FDA UDI
Model / Reference: 7-EMR-050 V6.01 FDA UDI
Description: A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery. FDA UDI

Identifiers

Catalog Number: 7-EMR-050 FDA UDI
Primary DI / UDI-DI: 05060359560513 FDA UDI
510(k) Number: K171983 FDA UDI
FDA Product Code: KNS FDA UDI
GMDN Term: Microwave/electrosurgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microwave/electrosurgical system generator

Croma Generator by Creo Medical, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Microwave/electrosurgical system generator.

Croma Generator — Creo Medical, Ltd. · Class II
Croma — Creo Medical, Ltd. · Class II

Cleared under the same submission

K171983 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Creo Medical, Ltd.

Sources (2)

FDA UDI ba8a3bc4-075c-4463-9c7a-8052a602fd02 37 fields · synced Jun 17, 2026
EUDAMED 1 fields · synced May 29, 2026