YESNG Patient Plate #80226

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K881144 ↗

FDA Product Code

JOS

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the YESNG Patient Plate #80226 used for?

  The YESNG Patient Plate #80226 is an electrosurgical electrode designed to serve as a grounding pad during electrosurgical procedures. It completes the electrical circuit, ensuring safe current flow from the surgical instrument to the patient while minimizing the risk of tissue damage or burns. This is critical for maintaining patient safety during operations.

• Is the YESNG Patient Plate #80226 sterile when supplied?

  Yes, the YESNG Patient Plate #80226 is supplied sterile. This ensures it can be safely used immediately upon opening without additional sterilization, adhering to best practices for single-use medical devices in surgical settings.

• Can the YESNG Patient Plate #80226 be reused?

  No, the YESNG Patient Plate #80226 is intended for single-use only. Reuse is not recommended as it compromises sterility and safety standards, potentially increasing the risk of infection or electrical hazards during subsequent procedures.

• What regulatory classification does the YESNG Patient Plate #80226 hold?

  The YESNG Patient Plate #80226 is classified as a Class II medical device under FDA regulations. It received 510(k) clearance (K881144) under the Substantially Equivalent determination, indicating it meets FDA safety and effectiveness requirements for its intended use in electrosurgery.

• How should the YESNG Patient Plate #80226 be stored?

  The YESNG Patient Plate #80226 should be stored in its original, sealed packaging until ready for use. Proper storage ensures sterility is maintained. Avoid exposure to moisture, extreme temperatures, or contamination, as these factors could compromise the device’s integrity and safety.