SCD Therapeutic Stocking System
by Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) K902497
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902497 | Date15 Aug 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- Withdrawn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
- 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 SCD Therapeutic Stocking System is a medical support stocking designed to prevent pooling of blood in the legs. It is classified as a Class II device under FDA regulation number 880.5780 and is identified by the product code DWL.
The system received FDA 510(k) clearance (K902497) on August 15, 1990, and is manufactured by Kendall Healthcare Products Co., a division of Tyco Health. It is supplied as a non-sterile, reusable device intended for use in general hospital settings.
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Questions
AI-generated answers, 19 Sep 2026
What is the SCD Therapeutic Stocking System intended to do?
The SCD Therapeutic Stocking System is designed to prevent pooling of blood in the legs, as stated in the device description. It functions as a medical support stocking for this purpose in general hospital settings.
Is the SCD Therapeutic Stocking System sterile or non-sterile when supplied?
The device is supplied as a non-sterile product, as explicitly stated in the description under specifications. It is not provided in a sterile condition and requires appropriate handling prior to use.
Can the SCD Therapeutic Stocking System be reused, or is it single-use?
The SCD Therapeutic Stocking System is classified as a reusable device, as indicated in the description. It is intended for multiple uses in general hospital environments, not for single-use disposal.
What regulatory pathway was used for the SCD Therapeutic Stocking System?
The device received FDA 510(k) clearance via the traditional pathway, as shown by the clearance_type field and the K902497 number. It was found substantially equivalent to a predicate device, leading to its Class II classification.
What is the product code and regulation number for the SCD Therapeutic Stocking System?
The product code is DWL and the regulation number is 880.5780, both directly from the device data. These identifiers classify it as a medical support stocking under FDA regulations for general hospital use.