Name: Predicase
Price: 199 USD

K-number	K231405
Device name	Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
Applicant	Jiangsu Rong FU Kang Medical Instruments Co., Ltd.
Product code	GEI
Device class	Class II
Decision date	Jan 18, 2024
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.