Cp-Sleeve
FDA 510(k) K013975 · Cp Medical
510(k) numberK013975
Submission
- Device name
- Cp-Sleeve
- Applicant
- Cp Medical
Portland, OR, US - Received
- December 3, 2001
- Decision date
- February 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Isoray Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173922 | C-PTFETM Surgical SutureNBY · Traditional | 03/26/2018SE |
| K094028 | Cp-Fiber (Orthofiber)GAT · Abbreviated | 03/18/2010SE |
| K072229 | MonoswiftGAM · Abbreviated | 10/05/2007SE |
| K071550 | Pre-Waxed Needles with Gold Fiduciary MarkersKXK · Abbreviated | 07/18/2007SE |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31MTJ · Traditional | 11/02/2006SE |
| K041894 | OrthofiberGAT · Special | 09/17/2004SE |
| K034062 | CP Sleeve and River SleeveKXK · Special | 01/30/2004SE |
| K024372 | CP Medical Bone WaxMTJ · Traditional | 06/19/2003SE |
| K030786 | Mono-SwiftNEW · Abbreviated | 05/06/2003SE |
| K030351 | Stainless Steel Surgical Suture, Non-AbsorbableGAQ · Abbreviated | 03/28/2003SE |
Questions and answers
When was Cp-Sleeve cleared by the FDA?
Cp-Sleeve (K013975) received a 510(k) decision of Substantially Equivalent on February 22, 2002, 81 days after the submission was received.
What is the product code of K013975?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.