Modification to Accu-Space Plain Gut Absorbable Seeding Spacers
FDA 510(k) K013964 · Cp Medical
510(k) numberK013964
Submission
- Device name
- Modification to Accu-Space Plain Gut Absorbable Seeding Spacers
- Applicant
- Cp Medical
Portland, OR, US - Received
- December 3, 2001
- Decision date
- January 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252296 | OncoPatchKXK · Traditional | Oncopatch, Inc. | 12/05/2025SE |
| K242818 | IsoSphereKXK · Traditional | Isoaid, LLC | 07/15/2025SE |
| K223465 | RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional | Radiance Therapeutics, Inc. | 01/11/2023SE |
| K221539 | GammaTileKXK · Traditional | Gt Medical Technologies | 11/09/2022SE |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional | Isoray Medical, Inc. | 12/31/2020SE |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special | Lv Liberty Vision Corporation | 05/29/2020SE |
| K190839 | GammaTileKXK · Traditional | Gt Medical Technologies | 01/23/2020SE |
| K191324 | CivaDermKXK · Traditional | Civatech Oncology, Inc. | 09/20/2019SE |
| K190296 | GammaTileKXK · Special | Gt Medical Technologies | 03/13/2019SE |
| K180515 | GammaTileKXK · Traditional | Isoray Medical, Inc. | 07/06/2018SE |
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 Modification to Accu-Space Plain Gut Absorbable Seeding Spacers cleared by the FDA?
Modification to Accu-Space Plain Gut Absorbable Seeding Spacers (K013964) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 52 days after the submission was received.
What is the product code of K013964?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.