Markit Tissue MARKER-1ML Markit Tissue MARKER-3ML Markit Tissue MARKER-10ML

FDA 510(k) K121964 · Augmenix, Inc.

Substantially Equivalent

510(k) numberK121964

Submission

Device name
Markit Tissue MARKER-1ML Markit Tissue MARKER-3ML Markit Tissue MARKER-10ML
Applicant
Augmenix, Inc.
Waltham, MA, US
Received
July 5, 2012
Decision date
January 23, 2013
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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K252892SCOUT MD Surgical Guidance SystemNEU · Traditional Merit Medical Systems, Inc.12/19/2025SE
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K243642UltraCor™ Twirl™ Breast Tissue MarkerNEU · Traditional Bard Peripheral Vascular, Inc.03/24/2025SE
K233639SmartClip Secure Soft Tissue MarkerNEU · Traditional Elucent Medical, Inc.12/20/2024SE
K240429Trilogy Tissue MarkerNEU · Traditional Inrad, Inc.11/07/2024SE
K234149MOLLI 2 SystemNEU · Traditional Molli Surgical, Inc.09/26/2024SE
K240042MOLLI 2 SystemNEU · Traditional Molli Surgical, Inc.09/25/2024SE

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K151998TraceIT Tissue Marker - 3mLNEU · Special 08/19/2015SE

Questions and answers

When was Markit Tissue MARKER-1ML Markit Tissue MARKER-3ML Markit Tissue MARKER-10ML cleared by the FDA?

Markit Tissue MARKER-1ML Markit Tissue MARKER-3ML Markit Tissue MARKER-10ML (K121964) received a 510(k) decision of Substantially Equivalent on January 23, 2013, 202 days after the submission was received.

What is the product code of K121964?

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