FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXXENT SURFACE APPLICATOR, MODEL 710257
K Number: K083734
·
Decision Feb 11, 2009
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
6
Review Days
57
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
- AXXENT SURFACE APPLICATOR, MODEL 710257
- K Number
- K083734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xoft, Inc.
- Date Received
- December 16, 2008
- Decision Date
- February 11, 2009
- Product Code
- JAD
- 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 |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAD), ordered by most recent decision date.
GentleBeam (GB1000)
FDA 510(k)
FDA Class 2
·Radiology
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
FDA 510(k)
FDA Class 2
·Radiology
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
FDA 510(k)
FDA Class 2
·Radiology
Esteya
FDA 510(k)
FDA Class 2
·Radiology
Sensus IORT System
FDA 510(k)
FDA Class 2
·Radiology
Sensus Healthcare TVM Balloon Applicator
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Xoft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E | Jul 16, 2009 | Unknown |
| K090417 | AXXENT FLEXISHIELD MINI | Jun 23, 2009 | Substantially Equivalent |
| K072616 | AXXENT VAGINAL APPLICATOR | May 9, 2008 | Substantially Equivalent |
| K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Feb 29, 2008 | Unknown |
| K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Dec 22, 2005 | Unknown |