FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IOVERA
K Number: K133453
·
Decision Mar 24, 2014
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
22
Applicant Total
9
Review Days
132
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Basic Information
- Device Name
- IOVERA
- K Number
- K133453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Myoscience, Inc.
- Date Received
- November 12, 2013
- Decision Date
- March 24, 2014
- Product Code
- GXH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXH | Device, Surgical, Cryogenic | FDA class 2 | Neurology |
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Other Clearances by Myoscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173763 | iovera system | Feb 28, 2018 | Substantially Equivalent |
| K161835 | iovera system | Mar 24, 2017 | Substantially Equivalent |
| K142866 | Myoscience iovera system | Jan 21, 2015 | Substantially Equivalent |
| K123516 | CRYO-TOUCH IV | Jan 10, 2013 | Substantially Equivalent |
| K120415 | CRYO-TOUCH III | Jun 22, 2012 | Substantially Equivalent |
| K102021 | CRYO-TOUCH II | Sep 17, 2010 | Substantially Equivalent |
| K100447 | MYOSCIENCE CRYO-TOUCH | Jun 25, 2010 | Substantially Equivalent |
| K083493 | MYOSCIENCE CRYO-TOUCH | Mar 20, 2009 | Substantially Equivalent |