ReFlow System Mini

FDA 510(k) K221918 · Anuncia Medical, Inc.

Substantially Equivalent

510(k) numberK221918

Submission

Device name
ReFlow System Mini
Applicant
Anuncia Medical, Inc.
Scottsdale, AZ, US
Received
July 1, 2022
Decision date
September 29, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 ReFlow System Mini cleared by the FDA?

ReFlow System Mini (K221918) received a 510(k) decision of Substantially Equivalent on September 29, 2022, 90 days after the submission was received.

What is the product code of K221918?

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