FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MODIFICATION TO: SAVI APPLICATOR KIT
K Number: K080565
·
Decision Apr 4, 2008
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- MODIFICATION TO: SAVI APPLICATOR KIT
- K Number
- K080565
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cianna Medical, Inc.
- Date Received
- February 29, 2008
- Decision Date
- April 4, 2008
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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Other Clearances by Cianna Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Aug 2, 2018 | Substantially Equivalent |
| K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Oct 31, 2017 | Substantially Equivalent |
| K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Jul 29, 2016 | Substantially Equivalent |
| K141318 | CIANNA MEDICAL SGS SYSTEM | Aug 27, 2014 | Substantially Equivalent |
| K132463 | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM | Dec 3, 2013 | Substantially Equivalent |
| K101411 | SAVI PREPARATION DEVICE | Jul 12, 2010 | Substantially Equivalent |
| K081677 | SAVI APPLICATOR KIT | Jul 22, 2008 | Unknown |