Kobold Ring and Tandem Applicator Set

FDA 510(k) K142330 · Kobold, LLC

Substantially Equivalent

510(k) numberK142330

Submission

Device name
Kobold Ring and Tandem Applicator Set
Applicant
Kobold, LLC
Liberty Lake, WA, US
Received
August 20, 2014
Decision date
April 9, 2015
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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More from Braxx Biotech Co., Ltd.

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K170203System, Applicator, Radionuclide, Remote ControlledJAQ · Traditional 06/01/2017SE
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Questions and answers

When was Kobold Ring and Tandem Applicator Set cleared by the FDA?

Kobold Ring and Tandem Applicator Set (K142330) received a 510(k) decision of Substantially Equivalent on April 9, 2015, 232 days after the submission was received.

What is the product code of K142330?

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