Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set

FDA 510(k) K160610 · Kobold, LLC

Substantially Equivalent

510(k) numberK160610

Submission

Device name
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
Applicant
Kobold, LLC
Veradale, WA, US
Received
March 3, 2016
Decision date
February 13, 2017
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 Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set cleared by the FDA?

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set (K160610) received a 510(k) decision of Substantially Equivalent on February 13, 2017, 347 days after the submission was received.

What is the product code of K160610?

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