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Orion Sterile Or Towels

by Orion Life Systems, Inc.

510(k) K903117

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK903117 Date31 Dec 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Orion Sterile Or Towels is a medical device used for surgical procedures, providing a sterile or towel solution for healthcare professionals. As a substantially equivalent device, it is designed to meet specific medical needs. The device is classified under the product code KKX.

The Orion Sterile Or Towels is supplied as a sterile product and is intended for single-use. It is available in various sizes, although specific sizes are not listed. The device has received FDA 510K authorization, with a decision date of 1990-12-31 and k_number K903117. The device is manufactured by Orion Life Systems, Inc.

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See all devices from Orion Life Systems, Inc. →

Questions

AI-generated answers, 6 Oct 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 Orion Sterile Or Towels used for?

    The Orion Sterile Or Towels is used for surgical procedures, providing a sterile or towel solution for healthcare professionals.

  • Is the Orion Sterile Or Towels supplied sterile?

    Yes, the Orion Sterile Or Towels is supplied as a sterile product, intended for single-use to ensure patient safety.

  • What sizes are the Orion Sterile Or Towels available in?

    The Orion Sterile Or Towels is available in various sizes, although specific sizes are not listed in the device information.