Disposable Grounding Pad

Q: What is the product code of K231985?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K231985 · Shenzhen Mecun Medical Supply Co., Ltd.

Substantially Equivalent

510(k) numberK231985

Submission

Device name: Disposable Grounding Pad
Applicant: Shenzhen Mecun Medical Supply Co., Ltd.
Shenzhen, CN
Received: July 5, 2023
Decision date: February 16, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code GEI

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K253859	Scarlet Pro (Scarlet Pro)GEI · Traditional	VIOL Co., Ltd.	08/27/2026SE
K252535	Inno-Switch Laparoscopic InstrumentsGEI · Traditional	Taiwan Surgical Corporation	08/25/2026SE
K261179	AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional	Gimmi GmbH	07/22/2026SE
K253504	VolnewmerGEI · Traditional	Classys, Inc.	07/13/2026SE
K254056	THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional	Olympus Medical Systems Corp.	07/01/2026SE
K253484	Lutronic GeniusGEI · Traditional	Cynosure Lutronic Technology Corporation	06/29/2026SE
K251492	Irrigation Tubing Bipolar Cord SetGEI · Traditional	New Deantronics Taiwan , Ltd.	06/29/2026SE
K260636	Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional	Stryker Sustainability Solutions	06/18/2026SE

510(k)	Device	Decision
K231979	Mecun SpO2 sensorDQA · Traditional	08/16/2024SE
K232460	Disposable electrosurgical pencil (MD1000)GEI · Traditional	10/11/2023SE

Questions and answers

When was Disposable Grounding Pad cleared by the FDA?

Disposable Grounding Pad (K231985) received a 510(k) decision of Substantially Equivalent on February 16, 2024, 226 days after the submission was received.

What is the product code of K231985?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.