FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
K Number: K092144
·
Decision Feb 22, 2010
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
27
Review Days
222
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Basic Information
- Device Name
- BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
- K Number
- K092144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endochoice, Inc.
- Date Received
- July 15, 2009
- Decision Date
- February 22, 2010
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Endochoice, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox Processor | Aug 1, 2016 | Substantially Equivalent |
| K161482 | EndoChoice Water Bottle Cap Irrigation System | Jun 27, 2016 | Substantially Equivalent |
| K161167 | Seal Single-Use Biopsy Valve | May 26, 2016 | Substantially Equivalent |
| K160403 | SmartStart Air/Water and Suction Valves | May 19, 2016 | Substantially Equivalent |
| K153588 | EndoChoice Water Bottle Cap System | Feb 24, 2016 | Substantially Equivalent |
| K151475 | EndoChoice Select Injection Needle | Feb 8, 2016 | Substantially Equivalent |
| K152182 | Fuse Gastroscopy System | Dec 10, 2015 | Substantially Equivalent |
| K152580 | rescuenet | Nov 3, 2015 | Substantially Equivalent |
| K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Jan 20, 2015 | Substantially Equivalent |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Oct 17, 2014 | Substantially Equivalent |