Smart External Drain (SED) System

Q: What is the product code of K161605?

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

FDA 510(k) K161605 · Aqueduct Critical Care, Inc.

Substantially Equivalent

510(k) numberK161605

Submission

Device name: Smart External Drain (SED) System
Applicant: Aqueduct Critical Care, Inc.
Bothell, WA, US
Received: June 10, 2016
Decision date: October 27, 2016
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

Other 510(k)s with product code JXG

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K261004	Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional	Integra Lifesciences Production Corporation	06/23/2026SE
K251598	IntellidropJXG · Traditional	Brainspace, Inc.	12/10/2025SE
K250636	Sophy Mini Monopressure Valve (SM1)JXG · Traditional	Sophysa	11/28/2025SE
K252514	Evac-MriJXG · Traditional	Phasor Health, LLC	11/05/2025SESD
K243531	Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional	Integra Lifesciences Production Corporation	08/08/2025SE
K243552	Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional	Integra Lifesciences Production Corporation	08/06/2025SE
K242974	External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional	Sophysa	06/20/2025SE
K243205	EvacJXG · Traditional	Phasor Health, LLC	06/03/2025SE
K243676	Duet External Drainage and Monitoring System (EDMS)JXG · Traditional	Medtronic Neurosurgery	03/10/2025SE
K242003	XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional	Aesculap, Inc.	12/16/2024SE

More from Aesculap, Inc.

510(k)	Device	Decision
K181301	Smart External Drain (SED) SystemJXG · Special	06/14/2018SE
K172759	Smart External Drain (SED) SystemJXG · Traditional	11/14/2017SE
K171586	Smart External Drain (SED) SystemJXG · Special	06/30/2017SE

Questions and answers

When was Smart External Drain (SED) System cleared by the FDA?

Smart External Drain (SED) System (K161605) received a 510(k) decision of Substantially Equivalent on October 27, 2016, 139 days after the submission was received.

What is the product code of K161605?

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