FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAROSTAT SOFTWARE OPTION
K Number: K120997
·
Decision Aug 27, 2012
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
12
Review Days
147
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Basic Information
- Device Name
- BAROSTAT SOFTWARE OPTION
- K Number
- K120997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crospon, Ltd.
- Date Received
- April 2, 2012
- Decision Date
- August 27, 2012
- Product Code
- FFX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | FDA class 2 | Gastroenterology, Urology |
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| K170833 | EndoFLIP® System with FLIP Topography module | Apr 17, 2017 | Substantially Equivalent |
| K160725 | EndoFLIP | May 1, 2016 | Substantially Equivalent |
| K142000 | ESOFLIP ES | Sep 25, 2014 | Substantially Equivalent |
| K132337 | ESOFLIP BALLOON DILATION CATHETER | Oct 7, 2013 | Substantially Equivalent |
| K130906 | ENDOFLIP CATHETER | Jul 17, 2013 | Substantially Equivalent |
| K110531 | ENDOFLIP ECD | Oct 6, 2011 | Substantially Equivalent |
| K110529 | ENDOFLIP GASTRIC TUBE | Jul 22, 2011 | Substantially Equivalent |
| K102214 | ENDO FLIP | Dec 16, 2010 | Substantially Equivalent |