Manufacturer
Zhejiang shuyou Surgical Instrument Co., Ltd.Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
Zhejiang shuyou Surgical Instrument Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260466
- Device name
- Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
- Country / Region
- China(CN)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2026-02-12
- Decision date
- 2026-04-07
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
Electrosurgical Pencil and Accessories designed for general electrosurgical applications, including cutting and coagulation, illumination and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The electrosurgical pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.
Intended Use
Electrosurgical Pencil and Accessories designed for general electrosurgical applications, including cutting and coagulation, illumination and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The electrosurgical pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Device Description
The electrosurgical pencil mainly consists of electrode, functional tube, insulating layer, plastic handle, manual button switch, cable, plug, Teflon material, suction tube joint, three-way valve. There are four main types of electrosurgical pencil, including SY-I, SY-II, SY-III and SY-IV. The design of the four types of electrosurgical pencil is different, and each type of electrosurgical pencil has differences in size and shape. The disposable electrode is composed of electrode shaft, insulation layer, or plastic handle. There are six main types of disposable electrode, including ordinary electrode, tungsten needle electrode, tungsten wire electrode, silicone electrode, endoscopic electrode and orthopedic electrode. The size and shape of the six types of disposable electrode is different.
Summary parsed at:2026-06-19 23:54:23 UTC
