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FDA 510(k)

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode

K-Number: K231405 · 2024-01-18

ApplicantJiangsu Rong FU Kang Medical Instruments Co., Ltd.
Decision Date2024-01-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is a medical device manufactured by Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-01-18 under approval number K231405. 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 Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. The 510(k) number is K231405.

When was Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode approved by the FDA?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode received FDA 510(k) clearance on 2024-01-18, under approval number K231405.

What company makes Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is manufactured by Jiangsu Rong FU Kang Medical Instruments Co., Ltd..

What is the FDA product code for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

The FDA product code for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is GEI.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

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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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