FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
K Number: K092458
·
Decision Aug 28, 2009
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
5
Review Days
17
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
- PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
- K Number
- K092458
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isoray Medical, Inc.
- Date Received
- August 11, 2009
- Decision Date
- August 28, 2009
- 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 Isoray Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Dec 31, 2020 | Substantially Equivalent |
| K180515 | GammaTile | Jul 6, 2018 | Substantially Equivalent |
| K111931 | GLIASITE RTS | Aug 5, 2011 | Substantially Equivalent |
| K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | Aug 7, 2009 | Substantially Equivalent |