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FDA 510(k)

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

K-Number: K240975 · 2024-12-23

ApplicantBeijing Taktvoll Technology Co., Ltd.
Decision Date2024-12-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Taktvoll Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K240975. 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 Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Beijing Taktvoll Technology Co., Ltd.. The 510(k) number is K240975.

When did Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) receive FDA 510(k) clearance?

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) received FDA 510(k) clearance on 2024-12-23, under 510(k) number K240975.

Who is the listed applicant for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

The FDA 510(k) record lists Beijing Taktvoll Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)?

The FDA product code for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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