FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXXENT VAGINAL APPLICATOR
K Number: K072616
·
Decision May 9, 2008
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
6
Review Days
235
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Basic Information
- Device Name
- AXXENT VAGINAL APPLICATOR
- K Number
- K072616
- 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
- September 17, 2007
- Decision Date
- May 9, 2008
- 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 |
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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 |
| K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 | Feb 11, 2009 | Substantially Equivalent |
| K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Feb 29, 2008 | Unknown |
| K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Dec 22, 2005 | Unknown |