Codman Skull Pins (Adult & Child), Reusable

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K912005 ↗

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. →

• Are these Codman Skull Pins meant for single-use or can they be reused in multiple procedures?

  These Codman Skull Pins are explicitly designed for reusable use, as stated in the device description. They are intended to be sterilized and used repeatedly in operating room settings, adhering to regulatory standards for reusable medical devices.

• How are these skull pins supplied, and are they sterile upon receipt?

  The Codman Skull Pins (Adult & Child) are supplied sterile, as noted in the device description. This ensures they meet operating room requirements without additional sterilization before first use, though they are intended for reuse after proper cleaning and reprocessing.

• What regulatory pathway was followed for FDA clearance of these skull pins, and what does that mean for their use?

  These pins were cleared via the FDA 510(k) process (K912005), classified as Class II with Special Controls, and reviewed by the Neurology (NE) Advisory Committee in 1991. The clearance determined they are substantially equivalent to a predicate device, meaning their safety and performance meet established regulatory standards for neurosurgical skull clamps.

• What sizes or models of Codman Skull Pins are available, and are they designed for both adult and pediatric patients?

  While the exact sizes or model variations aren’t detailed in the provided data, the device is explicitly labeled as Codman Skull Pins (Adult & Child), indicating it includes designs suitable for both adult and pediatric neurosurgical procedures. The OpenFDA registration numbers suggest multiple variants exist, but specifics would require manufacturer documentation.

• Where were these skull pins originally submitted to the FDA, and what was the decision date for clearance?

  The initial submission was filed at 41 Pacella Park Dr., Randolph, MA 02368, and the FDA clearance decision was made on September 19, 1991, following a review by the Neurology Advisory Committee. The clearance was granted under the Traditional 510(k) pathway with a decision code of SESE (Substantially Equivalent).