Readi-Strand, Model Psstrand
FDA 510(k) K023179 · Worldwide Medical Technologies, LLC
510(k) numberK023179
Submission
- Device name
- Readi-Strand, Model Psstrand
- Applicant
- Worldwide Medical Technologies, LLC
Woodbury, CT, US - Received
- September 24, 2002
- Decision date
- July 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K020337 | Readi-Strand; Model PsstrandKXK · Traditional | 07/29/2002SE |
| K020867 | Bone Marrow Aspiration Needle, Model BMB1110J, Bone Marrow Harvest Needle, Model…KNW · Traditional | 05/20/2002SE |
| K991344 | Worldwide Medical Technologies Seeding SpacersKXK · Traditional | 11/05/1999SE |
| K981889 | Worldwide Medical Technologies Introducer NeedleFCG · Traditional | 07/31/1998SE |
| K982097 | Worldwide Medical Technologies Intracervical Block Needle, Model TBDFMI · Traditional | 06/25/1998SE |
| K981470 | Worldwide Medical Technologies Needle GuideIZH · Traditional | 06/19/1998SE |
Questions and answers
When was Readi-Strand, Model Psstrand cleared by the FDA?
Readi-Strand, Model Psstrand (K023179) received a 510(k) decision of Substantially Equivalent on July 2, 2003, 281 days after the submission was received.
What is the product code of K023179?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.