Tissue Site Marking System

FDA 510(k) K062528 · Suros Surgical Systems, Inc.

Substantially Equivalent

510(k) numberK062528

Submission

Device name
Tissue Site Marking System
Applicant
Suros Surgical Systems, Inc.
Indianapolis, IN, US
Received
August 29, 2006
Decision date
January 26, 2007
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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Questions and answers

When was Tissue Site Marking System cleared by the FDA?

Tissue Site Marking System (K062528) received a 510(k) decision of Substantially Equivalent on January 26, 2007, 150 days after the submission was received.

What is the product code of K062528?

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