FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Seal Single-Use Biopsy Valve
K Number: K161167
·
Decision May 26, 2016
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
27
Review Days
30
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Basic Information
- Device Name
- Seal Single-Use Biopsy Valve
- K Number
- K161167
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endochoice, Inc.
- Date Received
- April 26, 2016
- Decision Date
- May 26, 2016
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCX), ordered by most recent decision date.
AUXILIARY WATER TUBE MAJ-855
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FDA Class 2
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Single-Use Biopsy Valve (MAJ-1555)
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ArgoCap (200.52)
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Endoscopic Water Pump
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FDA Class 2
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Water Container (MAJ-901); Water Container (MAJ-902)
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FDA Class 2
·Gastroenterology, Urology
Aspiration Catheter (2189)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |
| K141598 | FUSE COLONOSCOPY SYSTEM | Sep 30, 2014 | Substantially Equivalent |