Bend-A-Beam Hand Control Malleable ABC Handpiece

• • Terminated Z-2277-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008

  The internal electrode protrudes in front of the ceramic insulator tip of the handpiece.

• • Terminated Z-2278-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008

  The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.

• • Terminated Z-2276-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008

  The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece.

510(k) Number

K961505 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Bend-A-Beam Hand Control Malleable ABC Handpiece used for?

  This handpiece is designed to provide manual control and malleable positioning during general and plastic surgery procedures, allowing surgeons to adjust its shape for optimal access and manipulation in clinical settings.

• Is the Bend-A-Beam Hand Control Malleable ABC Handpiece sterile or non-sterile when supplied?

  The device is supplied as a non-sterile, reusable instrument, meaning it must be cleaned and sterilized by the healthcare facility before each use according to standard reprocessing protocols for reusable surgical tools.

• Can the Bend-A-Beam Hand Control Malleable ABC Handpiece be reused, and what are the implications for handling?

  Yes, it is intended for reuse; after each procedure, it must undergo proper cleaning, disinfection, and sterilization following institutional guidelines for reusable surgical instruments, as no single-use designation is indicated in the data.

• What regulatory pathway authorized the Bend-A-Beam Hand Control Malleable ABC Handpiece?

  The device received authorization through the FDA 510(k) process under submission K961505, with a determination of substantial equivalence to a predicate device, based on its intended use and technological characteristics.

• Are there any special storage or handling requirements for the Bend-A-Beam Hand Control Malleable ABC Handpiece?

  No specific storage or handling instructions are provided in the device data; therefore, standard practices for reusable surgical instruments should be followed, including storage in a clean, dry environment and adherence to manufacturer-recommended reprocessing procedures.