EKOS ultrasound EVD Device, EVD Control Unit

FDA 510(k) K172035 · Btg International, Inc.

Substantially Equivalent

510(k) numberK172035

Submission

Device name
EKOS ultrasound EVD Device, EVD Control Unit
Applicant
Btg International, Inc.
Bothell, WA, US
Received
July 5, 2017
Decision date
March 24, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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Questions and answers

When was EKOS ultrasound EVD Device, EVD Control Unit cleared by the FDA?

EKOS ultrasound EVD Device, EVD Control Unit (K172035) received a 510(k) decision of Substantially Equivalent on March 24, 2018, 262 days after the submission was received.

What is the product code of K172035?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.