Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set

FDA 510(k) K130757 · Spencer Fillmore

Substantially Equivalent

510(k) numberK130757

Submission

Device name
Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set
Applicant
Spencer Fillmore
San Francisco, CA, US
Received
March 20, 2013
Decision date
April 3, 2014
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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K241764Mould Probe MR SafeJAQ · Traditional Varian Medical Systems, Inc.01/10/2025SE
K242961Intraluminal Applicator SetJAQ · Traditional Varian Medical Systems11/26/2024SE
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More from Braxx Biotech Co., Ltd.

510(k)DeviceDecision
K123912Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetJAQ · Traditional 05/14/2013SE
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Questions and answers

When was Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set cleared by the FDA?

Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set (K130757) received a 510(k) decision of Substantially Equivalent on April 3, 2014, 379 days after the submission was received.

What is the product code of K130757?

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