External Drainage System (EDS and EDS II)

• • Terminated Z-1533-06 FDA Unclassified (pre-2012) ·initiated 4 Aug 2006 ·on shared 510(k) K954021

  Sterility of device is compromised due to package seal defects

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K954021 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• P.F.C. Uni-Compartmental Knee System

  Class II

  FDA 510(k) K954481 Active Cleared 10 Oct 1996

• J & J Cardiovascular Maxima Hollow Fiber Oxygenato

  Class II

  FDA 510(k) K853251 Active Cleared 16 Oct 1985

• Darwin Knee System (TC3)

  Class II

  FDA 510(k) K952830 Active Cleared 18 Jan 1996

• Adaptalite* Porcelain Veneer Cementation System

  Class II

  FDA 510(k) K871295 Active Cleared 29 May 1987

• Coman(R) Cu-11 Model Number 82-6634

  Class II

  FDA 510(k) K945585 Active Cleared 26 Oct 1995

• Fotofill Activator Light

  Class II

  FDA 510(k) K772278 Active Cleared 3 Jan 1978

See all devices from Johnson & Johnson Professionals, Inc. →

• What is the External Drainage System (EDS & EDS II) used for?

  The External Drainage System (EDS & EDS II) is designed for the external drainage of cerebrospinal fluid (CSF) from the brain or lumbar spine. It helps manage conditions like hydrocephalus by reducing intracranial pressure through controlled fluid removal. This system is specifically tailored for neurosurgical settings where precise CSF management is critical.

• Is the External Drainage System (EDS & EDS II) reusable or single-use?

  The External Drainage System (EDS & EDS II) is supplied as a reusable medical device. It is intended for use in sterile neurosurgical settings, meaning it must be properly cleaned, sterilized, and maintained between procedures to ensure safety and efficacy. Reusability is common for systems requiring rigorous sterilization protocols, like this one.

• What models or variants of the External Drainage System (EDS & EDS II) are available?

  The External Drainage System (EDS & EDS II) includes multiple model variants, though specific sizes or configurations are not detailed in the regulatory data. These variants are likely designed to accommodate different clinical needs, such as varying CSF flow rates or anatomical considerations. For precise specifications, consult the manufacturer’s product documentation or technical support.

• How should the External Drainage System (EDS & EDS II) be stored?

  The External Drainage System (EDS & EDS II) must be stored and handled according to sterile medical device protocols. Since it is reusable and intended for neurosurgical use, storage should follow FDA guidelines for Class II devices to maintain sterility and functionality. This includes proper packaging, environmental controls, and adherence to manufacturer instructions to prevent contamination or damage.

• What regulatory clearance does the External Drainage System (EDS & EDS II) hold?

  The External Drainage System (EDS & EDS II) holds a Traditional 510(k) clearance (K954021) from the FDA under the Neurology advisory committee. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in its intended use for external CSF drainage.