FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOFLIP ECD
K Number: K110531
·
Decision Oct 6, 2011
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
12
Review Days
224
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Basic Information
- Device Name
- ENDOFLIP ECD
- K Number
- K110531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crospon, Ltd.
- Date Received
- February 24, 2011
- Decision Date
- October 6, 2011
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Crospon, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K183072 | EndoFLIP System | Feb 15, 2019 | Substantially Equivalent |
| K172128 | EsoFLIP® ES-310 Balloon Catheter | Nov 22, 2017 | Substantially Equivalent |
| 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 |
| K120997 | BAROSTAT SOFTWARE OPTION | Aug 27, 2012 | Substantially Equivalent |
| K110529 | ENDOFLIP GASTRIC TUBE | Jul 22, 2011 | Substantially Equivalent |
| K102214 | ENDO FLIP | Dec 16, 2010 | Substantially Equivalent |