FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
K Number: K121795
·
Decision Feb 22, 2013
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
16
Applicant Total
8
Review Days
248
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Basic Information
- Device Name
- CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
- K Number
- K121795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cytophil, Inc.
- Date Received
- June 19, 2012
- Decision Date
- February 22, 2013
- Product Code
- MIX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| MIX | System, Vocal Cord Medialization | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Cytophil, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150400 | Renu Gel | Apr 6, 2015 | Substantially Equivalent |
| K102937 | OSTEOPHIL BETA-TCP | Dec 27, 2010 | Substantially Equivalent |
| K093871 | PERIOPHIL B-TCP | Apr 22, 2010 | Substantially Equivalent |
| K092788 | PERIOPHIL BIPHASIC | Dec 18, 2009 | Substantially Equivalent |
| K081815 | VOCALIS GEL | Jan 5, 2009 | Substantially Equivalent |
| K081816 | VOCALIS AND VOCALIS SM | Jan 5, 2009 | Substantially Equivalent |
| K072219 | CYTOPHIL TISSUE MARKER | Jan 18, 2008 | Substantially Equivalent |