Disposable Icp Kit Diff. Sizes

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K840003 ↗

FDA Product Code

GWM

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Codman Bactiseal EVD Catheter Set

  Class II

  FDA 510(k) K021653 Active Cleared 29 Jul 2002

• Codman* External Drainage System II (Eds-II)

  Class II

  FDA 510(k) K902257 Active Cleared 19 Jul 1990

• Orbit Galaxy G2 Microcoil Delivery System

  Class II

  FDA 510(k) K120686 Active Cleared 4 Apr 2012

• Charnley Femoral Component

  Class II

  FDA 510(k) K760974 Active Cleared 16 Nov 1976

• Vanderbilt Pituitary Retractor

  Class I

  FDA 510(k) K761096 Active Cleared 30 Nov 1976

• Codman Isocool Bipolar Forceps

  Class II

  FDA 510(k) K083895 Active Cleared 23 Jun 2009

See all devices from Codman & Shurtleff, Inc. →

• What is the Codman Disposable ICP Kit used for?

  The Codman Disposable ICP Kit is designed for measuring and monitoring intracranial pressure (ICP) in clinical settings, particularly in neurology. It helps assess and manage conditions like traumatic brain injury, hydrocephalus, or intracranial hemorrhage by providing real-time pressure readings within the cranial cavity. The kit’s components enable accurate monitoring, supporting critical decision-making for patient care.

• How is the Codman Disposable ICP Kit supplied, and what sizes are available?

  The kit is supplied in multiple sizes to accommodate different patient needs, ensuring compatibility with various clinical scenarios. It is intended for single-use applications only, adhering to sterile medical device standards. The exact sizing details are included in the kit’s packaging, but it is engineered to provide flexibility for intracranial monitoring across diverse cases.

• Is the Codman Disposable ICP Kit sterile, and how should it be stored?

  While the kit is intended for sterile use in clinical environments, specific sterility assurances (e.g., terminal sterilization method or sterility assurance level) are not detailed in the provided data. To maintain integrity and functionality, storage should follow standard medical device protocols: keep in a clean, dry environment, away from direct sunlight or extreme temperatures, and use within the manufacturer’s recommended shelf life. Always verify packaging integrity before use.

• Can the Codman Disposable ICP Kit be reused, or is it single-use?

  The Codman Disposable ICP Kit is explicitly designed for single-use only. Reuse is not recommended or supported, as it could compromise sterility, accuracy, or patient safety. Single-use devices are engineered for one-time clinical application to minimize infection risks and ensure reliable performance. Always adhere to the manufacturer’s instructions for proper disposal after use.

• What regulatory pathway does the Codman Disposable ICP Kit follow?

  The kit was cleared via the FDA 510(k) pathway under the Neurology advisory committee in 1984 (K840003). It is classified as a Class II medical device under FDA regulation 882.1620, indicating it poses moderate risk and requires premarket notification to ensure safety and effectiveness. The clearance demonstrates compliance with FDA standards for intracranial pressure monitoring devices.