Ameritek Sure-Point HDR Needle Template

FDA 510(k) K031273 · Amertek Medical, Inc.

Substantially Equivalent

510(k) numberK031273

Submission

Device name
Ameritek Sure-Point HDR Needle Template
Applicant
Amertek Medical, Inc.
Singer Island, FL, US
Received
April 22, 2003
Decision date
July 15, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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Questions and answers

When was Ameritek Sure-Point HDR Needle Template cleared by the FDA?

Ameritek Sure-Point HDR Needle Template (K031273) received a 510(k) decision of Substantially Equivalent on July 15, 2003, 84 days after the submission was received.

What is the product code of K031273?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.