Codman Skull Clamp

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K912011 ↗

FDA Product Code

HBL

Device Class

Class II

Regulation

21 CFR Part 882.4460

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 Skull Clamp used for?

  The Codman Skull Clamp is designed specifically for neurosurgical procedures to secure a patient’s skull. It maintains precise head and neck positioning, which is critical for providing stable surgical access and facilitating accurate surgical interventions during cranial operations.

• Is the Codman Skull Clamp intended for single-use or reuse?

  The Codman Skull Clamp is intended for single-use only in sterile operating room environments. This design ensures patient safety by preventing cross-contamination and maintaining sterility throughout surgical procedures.

• What regulatory approval does the Codman Skull Clamp hold?

  The Codman Skull Clamp holds FDA 510(k) clearance (K912011) and is classified under product code HBL as a neurosurgical head holder. It adheres to Class II with Special Controls, meeting regulatory requirements for neurosurgical instruments.

• How is the Codman Skull Clamp supplied, and what should be considered for storage?

  The Codman Skull Clamp is supplied sterile and packaged for single-use. It should be stored in a clean, dry environment, protected from moisture and physical damage. Follow manufacturer guidelines for shelf-life and expiration dates to ensure optimal performance and sterility.

• Are there multiple models or sizes available for the Codman Skull Clamp?

  While the provided data does not specify exact sizes or models, the Codman Skull Clamp is distributed under multiple FEI numbers (e.g., 1000138491, 1721676, etc.), which may correspond to variations in design or configuration. For precise sizing or model-specific details, refer to the manufacturer’s documentation or contact Codman & Shurtleff, Inc.