TraceIT Tissue Marker - 3mL

FDA 510(k) K151998 · Augmenix, Inc.

Substantially Equivalent

510(k) numberK151998

Submission

Device name
TraceIT Tissue Marker - 3mL
Applicant
Augmenix, Inc.
Waltham, MA, US
Received
July 20, 2015
Decision date
August 19, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement 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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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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Questions and answers

When was TraceIT Tissue Marker - 3mL cleared by the FDA?

TraceIT Tissue Marker - 3mL (K151998) received a 510(k) decision of Substantially Equivalent on August 19, 2015, 30 days after the submission was received.

What is the product code of K151998?

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