Co-Ablation System with Sterile Co-Ablation Probe (K243042)
Description
Co-Ablation System with Sterile Co-Ablation Probe by Hygea Medical Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243042
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Co-Ablation System with Sterile Co-Ablation Probe (K243042) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. | 2024 |
| K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023 |
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round... | Varian Medical Systems, Inc. | 2020 |
Trace the full predicate network for K243042
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.