Multifunctional Operational Dissectors (Electrosurgical Pencils) +1 more— 510(k) K260466
Substantially EquivalentZhejiang shuyou Surgical Instrument Co., Ltd.
FDA 510(k) clearance K260466 for Multifunctional Operational Dissectors (Electrosurgical Pencils) +1 more, Substantially Equivalent on 2026-04-07. Applicant: Zhejiang shuyou Surgical Instrument Co., Ltd.. Device class: 2.
Summary
Zhejiang shuyou Surgical Instrument's record names two Multifunctional Operational Dissectors listings, one for Electrosurgical Pencils and one for a Disposable Electrode. Both are filed under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Zhejiang shuyou Surgical Instrument filed from Huzhou, China. The decision came 54 calendar days after FDA received it (February 12 to April 7, 2026).
Clearance details
- Device name as filed
- Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
- Applicant
- Zhejiang shuyou Surgical Instrument Co., Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huzhou, CN
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.