Codman Single and Double Lumen Skull Bolt Kits

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992591 ↗

FDA Product Code

GWM

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  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

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  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. →