Chuck Handle

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K864771 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Chisel (Osteotome, Gouge, Etc.)

  Class I

  FDA 510(k) K864775 Active Cleared 12 Feb 1987

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  FDA 510(k) K880863 Active Cleared 19 Apr 1988

• Bipolar Coagulating Forceps

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  FDA 510(k) K811820 Active Cleared 28 Jul 1981

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  FDA 510(k) K831236 Active Cleared 2 Jun 1983

• Raney and Leroy-Raney Scalp Clip

  Class II

  FDA 510(k) K883963 Active Cleared 7 Oct 1988

• Cranio Blades and Wire Pass Drill

  Class I

  FDA 510(k) K861876 Active Cleared 30 May 1986

See all devices from New England Surgical Instrument Corp. →

• What is the Chuck Handle designed for in surgical procedures?

  The Chuck Handle is specifically designed to secure and manipulate fine surgical tools during procedures, ensuring precise control and stability. Its round, serrated grip reduces slippage, minimizing the risk of accidental detachment of instruments—critical for delicate surgical applications in general and plastic surgery.

• Is the Chuck Handle reusable or single-use?

  This device is intended for reuse. As a reusable surgical instrument, it must be cleaned and sterilized according to established medical device reprocessing guidelines to maintain safety and functionality between uses.

• What are the key physical specifications of the Chuck Handle?

  The Chuck Handle features a 10 cm length and a serrated texture on its grip, which enhances control and prevents slippage during use. These specifications are tailored to provide stability when securing and manipulating surgical tools in precise applications.

• How should the Chuck Handle be stored and maintained?

  Since this is a reusable instrument, it must be stored in a clean, dry environment to prevent contamination. After each use, it should undergo thorough cleaning and sterilization following standard medical device reprocessing protocols to ensure sterility and readiness for subsequent procedures.

• What regulatory pathway does the Chuck Handle follow?

  The Chuck Handle is regulated under the FDA’s 510(k) clearance process, specifically classified under product code GEI. It was granted clearance (K864771) in 1987 as substantially equivalent to a predicate device, ensuring compliance with U.S. regulatory standards for surgical instruments.