Readi-Strand, Model PSSTRAND
by Worldwide Medical Technologies, LLC 2 variants
510(k) K023179
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023179 | Date2 Jul 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5730
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Readi-Strand, Model PSSTRAND, is a brachytherapy device classified as a source for radionuclide delivery. It functions as a carrier for radioactive seeds used in internal radiation therapy, facilitating precise placement within the body during brachytherapy procedures. This device is designed to ensure accurate and controlled delivery of radionuclide seeds, primarily for targeted treatment applications.
The Readi-Strand, Model PSSTRAND, is intended for single-use in clinical settings and is supplied sterile. It is used in radiology departments for transperineal brachytherapy, particularly in procedures involving the prostate gland. The device adheres to FDA 510(k) clearance under the classification of Class II medical devices, with regulatory oversight under the code 892.5730. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.
Other devices from Worldwide Medical Technologies, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Readi-Strand PSSTRAND used for in medical procedures?
The Readi-Strand PSSTRAND is designed as a carrier for radioactive seeds in brachytherapy, specifically for internal radiation therapy. It ensures accurate and controlled placement of radionuclide seeds during transperineal procedures, particularly in the treatment of the prostate gland. This precision delivery helps target cancerous tissues while minimizing exposure to surrounding healthy tissue.
How is the Readi-Strand PSSTRAND supplied and what are its sterility requirements?
The Readi-Strand PSSTRAND is supplied sterile and intended for single-use only in clinical settings. Sterility is critical to prevent contamination during brachytherapy procedures, ensuring patient safety and device efficacy. Always follow sterile medical device protocols for storage and handling to maintain its integrity before use.
Is the Readi-Strand PSSTRAND reusable or designed for one-time use?
The Readi-Strand PSSTRAND is explicitly designed for single-use only. This design choice aligns with best practices for sterile medical devices, reducing the risk of cross-contamination and ensuring consistent performance for each procedure. Reuse is not recommended or supported by the manufacturer.
What regulatory approval does the Readi-Strand PSSTRAND hold, and how is it classified?
The Readi-Strand PSSTRAND holds FDA 510(k) clearance and is classified as a Class II medical device under the product code 892.5730. This classification indicates that it has been determined to be substantially equivalent to a predicate device already on the market, meeting regulatory standards for safety and effectiveness in brachytherapy applications.
How should the Readi-Strand PSSTRAND be stored to maintain its integrity?
The Readi-Strand PSSTRAND must be stored according to sterile medical device protocols to preserve its integrity. This includes keeping it in a sealed, sterile packaging until immediately before use, protecting it from physical damage, contamination, or exposure to extreme temperatures. Always refer to the manufacturer’s instructions for specific storage guidelines to ensure optimal performance and safety.