Codman Laser Backstop

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853626 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

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)

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  FDA 510(k) K902257 Active Cleared 19 Jul 1990

• Orbit Galaxy G2 Microcoil Delivery System

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  FDA 510(k) K120686 Active Cleared 4 Apr 2012

• Charnley Femoral Component

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  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

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  FDA 510(k) K083895 Active Cleared 23 Jun 2009

See all devices from Codman & Shurtleff, Inc. →

• What is the Codman Laser Backstop used for?

  The Codman Laser Backstop is a powered laser surgical instrument designed to provide a backstop function during laser surgery in general and plastic procedures, protecting surrounding tissues from laser energy.

• Is the Codman Laser Backstop a single-use or reusable instrument?

  The Codman Laser Backstop is supplied as a reusable instrument intended for multiple uses in surgical settings where laser energy is applied, provided it is properly cleaned and sterilized between procedures.

• What regulatory approvals does the Codman Laser Backstop have?

  The Codman Laser Backstop received FDA 510(k) clearance (K853626) on February 7, 1986, and is classified under product code GEX. It has been determined to be substantially equivalent to predicate devices.

• How is the Codman Laser Backstop supplied?

  The Codman Laser Backstop is supplied as a reusable surgical instrument that requires proper cleaning and sterilization between uses. It is intended for use in surgical settings where laser energy is applied during procedures.