Carolina Narrow Fabric Company Closed Toe Anti-Embolism Stocking
510(k) K961177
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961177 | Date15 Apr 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- Withdrawn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, 19 Sep 2026
The Carolina Narrow Fabric Company Closed Toe Anti-Embolism Stocking is a medical support device classified as a stocking designed to prevent pooling of blood in the legs. It is intended for use as a compression garment to reduce the risk of deep vein thrombosis and venous stasis in patients, particularly those at risk during immobilization or surgery.
This device is supplied as a single-use, non-sterile compression stocking and is regulated under FDA 510(k) clearance (K961177) as a Class II medical device under product code DWL. It is intended for use in general hospital settings and must be applied correctly to ensure proper function. Multiple sizes are available, as indicated by the registration numbers, and compliance with FDA regulations ensures its safety and performance.
Other devices from Carolina Narrow Fabric Co.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Carolina Narrow Fabric Company Closed Toe Anti-Embolism Stocking?
This stocking is designed as a compression garment to help prevent blood pooling in the legs, reducing the risk of deep vein thrombosis (DVT) and venous stasis. It is specifically intended for patients at risk during immobilization or surgery, such as those in general hospital settings.
Are these stockings meant for single-use or can they be reused?
The Carolina Narrow Fabric Company Closed Toe Anti-Embolism Stocking is explicitly supplied as a single-use device. Reuse is not recommended or supported by the manufacturer or regulatory clearance.
How many sizes are available for this stocking, and how do I determine the correct fit?
Multiple sizes are available, as indicated by the listed registration numbers (e.g., 3007123908, 3009211636, etc.). The correct size should be selected based on the patient’s leg measurements, following standard sizing guidelines for compression stockings. The manufacturer does not provide explicit sizing charts in the data, so clinical or hospital protocols should guide selection.
Is this stocking sterile, and if not, what precautions should be taken during application?
The stocking is non-sterile, meaning it is not intended for sterile procedures. To minimize infection risk, ensure proper hygiene (e.g., clean skin preparation) before application, and follow standard infection control practices when handling or applying the device.
What regulatory pathway was followed for this device, and where is it cleared for use?
This device was cleared through the FDA 510(k) pathway (traditional review, clearance number K961177) as a Class II medical device under product code DWL. It is intended for use in general hospital settings and complies with FDA regulations for compression stockings to prevent blood pooling in the legs.