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Reprocessed Compression Limb Sleeves

by Surgical Instruments Service and Savings, Inc.

510(k) K012658

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012658 Date14 May 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1638-2013 FDA Class II initiated 3 May 2013

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOW
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Reprocessed Compression Limb Sleeves are a type of compressible limb sleeve used to provide sequential compression to lower limbs, helping to prevent deep vein thrombosis. They are designed to be used with external pump systems. The sleeves function by wrapping around the patient's limbs and are connected to a pump to facilitate compression cycles.

The Reprocessed Compression Limb Sleeves are supplied as reprocessed single-use devices, which involves cleaning, functional testing, packaging, and sterilization of sleeves from various original equipment manufacturers. They are regulated under the product code JOW and have been found to be substantially equivalent, with an FDA 510(k) number of K012658.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of Reprocessed Compression Limb Sleeves?

    The Reprocessed Compression Limb Sleeves are used to provide sequential compression to lower limbs, helping to prevent deep vein thrombosis.

  • How are the Reprocessed Compression Limb Sleeves supplied?

    The Reprocessed Compression Limb Sleeves are supplied as reprocessed single-use devices, which involves cleaning, functional testing, packaging, and sterilization of sleeves from various original equipment manufacturers.

  • Are the Reprocessed Compression Limb Sleeves regulated?

    Yes, the Reprocessed Compression Limb Sleeves are regulated under the product code JOW and have been found to be substantially equivalent, with an FDA 510(k) number of K012658.