IRRAflow Active Fluid Exchange System (AFES)

FDA 510(k) K231664 · Irras USA, Inc.

Substantially Equivalent

510(k) numberK231664

Submission

Device name
IRRAflow Active Fluid Exchange System (AFES)
Applicant
Irras USA, Inc.
San Diego, CA, US
Received
June 7, 2023
Decision date
October 19, 2023
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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More from Aesculap, Inc.

510(k)DeviceDecision
K222471IRRAflow Active Fluid Exchange System (AFES)JXG · Special 12/08/2022SE
K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG · Special 04/29/2020SE
K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG · Traditional 11/15/2019SE

Questions and answers

When was IRRAflow Active Fluid Exchange System (AFES) cleared by the FDA?

IRRAflow Active Fluid Exchange System (AFES) (K231664) received a 510(k) decision of Substantially Equivalent on October 19, 2023, 134 days after the submission was received.

What is the product code of K231664?

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