OneMark

FDA 510(k) K241762 · View Point Medical

Substantially Equivalent

510(k) numberK241762

Submission

Device name
OneMark
Applicant
View Point Medical
Carlsbad, CA, US
Received
June 20, 2024
Decision date
September 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
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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More from Molli Surgical, Inc.

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Questions and answers

When was OneMark cleared by the FDA?

OneMark (K241762) received a 510(k) decision of Substantially Equivalent on September 16, 2024, 88 days after the submission was received.

What is the product code of K241762?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.