ASSISTO Universal Applicator Clamping Device

Q: What is the product code of K201279?

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

FDA 510(k) K201279 · Geomed Medizin-Technik GmbH & Co. KG

Substantially Equivalent

510(k) numberK201279

Submission

Device name: ASSISTO Universal Applicator Clamping Device
Applicant: Geomed Medizin-Technik GmbH & Co. KG
Tuttlingen, DE
Received: May 13, 2020
Decision date: July 10, 2020
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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K242961	Intraluminal Applicator SetJAQ · Traditional	Varian Medical Systems	11/26/2024SE
K243045	BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special	Braxx Biotech Co., Ltd.	11/19/2024SE

More from Braxx Biotech Co., Ltd.

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K102048	Atraumatic Vascular ClampsDXC · Traditional	11/09/2010SE
K052745	Assisto Arm SystemsGWG · Traditional	11/23/2005SE

Questions and answers

When was ASSISTO Universal Applicator Clamping Device cleared by the FDA?

ASSISTO Universal Applicator Clamping Device (K201279) received a 510(k) decision of Substantially Equivalent on July 10, 2020, 58 days after the submission was received.

What is the product code of K201279?

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