Lapin Clear Cut II

Q: When was Lapin Clear Cut II cleared by the FDA?

Lapin Clear Cut II (K812125) received a 510(k) decision of Substantially Equivalent on September 24, 1981, 59 days after the submission was received.

Q: What is the product code of K812125?

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) K812125 · Promed Corp.

Substantially Equivalent

510(k) numberK812125

Submission

Device name: Lapin Clear Cut II
Applicant: Promed Corp.
Mchenry, IL, US
Received: July 27, 1981
Decision date: September 24, 1981
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K913888	Med-Safe(Tm) Latex Examination GlovesLYY · Traditional	02/07/1992SE
K861091	EasistimKOI · Traditional	06/02/1986SE
K771892	Valve AnestheticCAD · Traditional	02/02/1978SE

Questions and answers

When was Lapin Clear Cut II cleared by the FDA?

Lapin Clear Cut II (K812125) received a 510(k) decision of Substantially Equivalent on September 24, 1981, 59 days after the submission was received.

What is the product code of K812125?

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