Carolina Narrow Fabric Company Open Toe Anti-Embolism Stocking
510(k) K960931
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960931 | Date23 May 1996 | 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- Withdrawn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
- DWL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5780
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Carolina Narrow Fabric Company Open Toe Anti-Embolism Stocking is a medical support stocking designed to apply controlled pressure to the leg. It is constructed of elastic material and is intended for medical purposes, specifically to prevent pooling of blood in the legs.
The stocking is supplied as a single unit and is intended for use in a general hospital setting. It is classified as a Class II device with the product code DWL and has been granted FDA 510(k) clearance under the regulation number 880.5780. The device is available in various sizes and is designed for single-use.
Other devices from Carolina Narrow Fabric Co.
Questions
AI-generated answers, 22 Sep 2026
What is the purpose of the Carolina Anti-Embolism Stocking?
The stocking is designed to apply controlled pressure to the leg to prevent pooling of blood, intended for medical purposes in a general hospital setting.
Is the Carolina Anti-Embolism Stocking supplied sterile?
The description does not explicitly state that the stocking is supplied sterile, but it is designed for single-use.
What sizes is the Carolina Anti-Embolism Stocking available in?
The device is available in various sizes to accommodate different patients' needs.
Can the Carolina Anti-Embolism Stocking be reused?
No, the stocking is designed for single-use.