Class Class II

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) (K240975)

K240975 2024-12-23 Traditional
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Description

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) by Beijing Taktvoll Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240975
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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Predicate lineage for K240975

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. Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) (K240975) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K134054BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AAR...Bovie Medical Corporation2014

Trace the full predicate network for K240975

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.

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