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FDA 510(k)

Disposable electrosurgical pencil (MD1000)

K-Number: K232460 · 2023-10-11

ApplicantShenzhen Mecun Medical Supply Co., Ltd.
Decision Date2023-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable electrosurgical pencil (MD1000) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mecun Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K232460. 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 Disposable electrosurgical pencil (MD1000)?

Disposable electrosurgical pencil (MD1000) is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Shenzhen Mecun Medical Supply Co., Ltd.. The 510(k) number is K232460.

When did Disposable electrosurgical pencil (MD1000) receive FDA 510(k) clearance?

Disposable electrosurgical pencil (MD1000) received FDA 510(k) clearance on 2023-10-11, under 510(k) number K232460.

Who is the listed applicant for Disposable electrosurgical pencil (MD1000)?

The FDA 510(k) record lists Shenzhen Mecun Medical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable electrosurgical pencil (MD1000)?

The FDA product code for Disposable electrosurgical pencil (MD1000) is GEI.

Other records listing Shenzhen Mecun Medical Supply Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231979Mecun SpO2 sensorK231985Disposable Grounding Pad

Related Devices (Code: 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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