Reprocessed Compression Sleeves

• • Ongoing Z-1612-2023 FDA Class II ·initiated 14 Apr 2023

  Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

510(k) Number

K100909 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K100254 Active Cleared 28 May 2010

• Reprocessed External Fixation Device

  Class II

  FDA 510(k) K061759 Active Cleared 5 Sep 2006

• Reprocessed Diagnostic Ultrasound Catheter

  Class II

  FDA 510(k) K063076 Active Cleared 29 Mar 2007

• Reprocessed Electrosurgical Instrument

  Class II

  FDA 510(k) K110189 Active Cleared 18 Jul 2011

• Reprocessed Trocars

  Class II

  FDA 510(k) K070059 Active Cleared 2 Oct 2007

• Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue

  Unclassified

  FDA 510(k) K100537 Active Cleared 12 May 2010

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• What are reprocessed compression sleeves used for?

  Reprocessed compression sleeves are designed to apply mechanical pressure to a limb when used within an external intermittent or sequential compression system. Their primary purpose is to promote venous return and reduce the risk of deep vein thrombosis (DVT), particularly in clinical settings like orthopedic, trauma, urologic, and critical care environments.

• Are these sleeves intended for single-use or reuse?

  These sleeves are initially supplied as single-use items before reprocessing. After undergoing a validated reprocessing procedure, they are intended for reuse to maintain safety and performance standards as specified by the manufacturer and regulatory guidelines.

• How should reprocessed compression sleeves be stored?

  To preserve sterility and functionality, reprocessed compression sleeves must be stored strictly according to the manufacturer’s guidelines. Proper storage ensures compliance with regulatory requirements for reprocessed medical devices and maintains their intended performance for clinical use.

• What types of clinical environments are these sleeves intended for?

  These sleeves are specifically intended for use in clinical settings such as orthopedic, trauma, urologic, and critical care environments. They are designed to support patients undergoing procedures or treatments where DVT risk is a concern.

• What regulatory approval does this device hold?

  The reprocessed compression sleeves hold FDA 510(k) clearance under the Cardiovascular advisory committee, with the clearance number K100909. This classification confirms they are substantially equivalent to a predicate device and meet regulatory standards for safety and effectiveness.