Orion Sterile Or Towels
510(k) K903117
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903117 | Date31 Dec 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Orion Life Systems, Inc.
Questions
AI-generated answers, 6 Oct 2026
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.