Reloadable Cutters, Staplers, and Appliers, Reprocessed

No FDA recalls on record, checked 6 Oct 2026.

Full name

Reprocessed Reloadable Cutters, Staplers, and Appliers

510(k) Number

K033578 ↗

FDA Product Code

NLL

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure Cuff

  Class II

  FDA 510(k) K031416 Active Cleared 15 Jul 2003

• Reprocessed Surgical Scissors and Graspers

  Class II

  FDA 510(k) K033592 Active Cleared 27 Jul 2004

• Clearmedical/Huntleigh Foot Garments; Models FG200/Lrg (Large), FG200/Std (Standard), FG100/Sm (Small), FG100-R (Regular

  Class II

  FDA 510(k) K012616 Active Cleared 6 Feb 2002

• Reprocessed Trocars

  Class I

  FDA 510(k) K033591 Active Cleared 3 Jun 2005

• Reprocessed Multiple Clip Appliers

  Class II

  FDA 510(k) K033579 Active Cleared 11 Jul 2005

• Clearmedical/Kendall Knee-High Scd Sleeves, Clearmedical/Kendall Thigh-High Scd Sleeves, Medium, Small, Large

  Class II

  FDA 510(k) K012606 Active Cleared 6 Feb 2002

See all devices from Clearmedical, Inc. →

• Are these reprocessed reloadable cutters and staplers intended for use in specific types of surgeries, and if so, which ones?

  These devices are designed for use in both alimentary tract and thoracic surgeries. They are specifically intended for tissue transection, resection, and anastomosis creation, which means they help with cutting tissue, removing sections, and reconnecting parts of the body during surgical procedures.

• How are these reloadable cutters and staplers supplied, and what does the reprocessing process entail?

  These devices are supplied as reprocessed, single-use surgical instruments that have undergone cleaning and sterilization to allow for reuse. The reprocessing ensures they meet safety and functionality standards for repeated surgical applications, though strict adherence to reprocessing protocols is required to maintain sterility and performance.

• Are these devices single-use only, or can they be reused after reprocessing, and what does that entail?

  While originally intended as single-use, these devices are reprocessed for reuse after undergoing cleaning and sterilization. Reprocessing involves thorough cleaning and sterilization to ensure they remain safe and functional for subsequent surgical procedures, but compliance with reprocessing standards is mandatory to avoid compromising safety.

• What regulatory pathway was followed for these reprocessed reloadable cutters and staplers, and what does that mean for their use?

  These devices received FDA clearance through a 510(k) submission (K033578) with a Substantially Equivalent (SESE) determination, meaning they were deemed comparable to a legally marketed predicate device. This clearance confirms they meet FDA safety and effectiveness standards for reprocessed, reloadable cutters and staplers used in tissue transection, resection, and anastomosis.

• What should clinicians consider when handling and storing these reprocessed reloadable cutters and staplers?

  Clinicians must follow reprocessing standards to ensure sterility and functionality after each use. Storage should be done in a clean, dry environment to prevent contamination, and handling should adhere to sterile techniques to maintain the device’s integrity for repeated surgical applications. Always refer to reprocessing guidelines to avoid compromising safety.