Neuromark System

FDA 510(k) K212666 · Neurent Medical

Substantially Equivalent

510(k) numberK212666

Submission

Device name
Neuromark System
Applicant
Neurent Medical
Galway, IE
Received
August 23, 2021
Decision date
October 22, 2021
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).

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Questions and answers

When was Neuromark System cleared by the FDA?

Neuromark System (K212666) received a 510(k) decision of Substantially Equivalent on October 22, 2021, 60 days after the submission was received.

What is the product code of K212666?

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