H-H External Ventricular Drain (Evd) Comp./Systems

Q: What is the product code of K870660?

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) K870660 · Holter-Hausner Intl.

Substantially Equivalent

510(k) numberK870660

Submission

Device name: H-H External Ventricular Drain (Evd) Comp./Systems
Applicant: Holter-Hausner Intl.
Bridgeport, PA, US
Received: February 19, 1987
Decision date: May 1, 1987
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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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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
K875287	H-H Flushing ReservoirJXG · Traditional	07/14/1988SE
K874508	H-H External Ventricular Drainage Collection BagJXG · Traditional	01/19/1988SE
K872293	H-H Hunter Active Tendon Implant BCHXA · Traditional	09/28/1987SN
K872285	H-H Hunter Active Tendon Implant DCHXA · Traditional	09/28/1987SN
K872284	H-H Hunter Active Tendon Implant PCHXA · Traditional	09/28/1987SN
K871351	H-H Harris Neonatal Nasal Cannula Set for CPAPBZD · Traditional	05/14/1987SE
K865075	H-H Subgaleal TrocarGYK · Traditional	01/13/1987SE
K853437	H-H Hunter Tendon Rod · Traditional	10/16/1985SE
K853436	H-H Hunter Passive Tendon ImplantHXR · Traditional	10/16/1985SE
K853438	H-H Hunter Active Tendon ImplantHXA · Traditional	09/30/1985SN

Questions and answers

When was H-H External Ventricular Drain (Evd) Comp./Systems cleared by the FDA?

H-H External Ventricular Drain (Evd) Comp./Systems (K870660) received a 510(k) decision of Substantially Equivalent on May 1, 1987, 71 days after the submission was received.

What is the product code of K870660?

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