FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K Number: K113210
·
Decision Aug 10, 2012
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
5
Review Days
283
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
- K Number
- K113210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isoaid, LLC
- Date Received
- November 1, 2011
- Decision Date
- August 10, 2012
- Product Code
- KXK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXK), ordered by most recent decision date.
OncoPatch
FDA 510(k)
FDA Class 2
·Radiology
IsoSphere
FDA 510(k)
FDA Class 2
·Radiology
RadianceTx Radionuclide Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology
GammaTile
FDA 510(k)
FDA Class 2
·Radiology
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
FDA 510(k)
FDA Class 2
·Radiology
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Isoaid, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K242818 | IsoSphere | Jul 15, 2025 | Substantially Equivalent |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Dec 5, 2014 | Substantially Equivalent |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA | Sep 15, 2009 | Substantially Equivalent |
| K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | Apr 8, 2004 | Substantially Equivalent |