FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOCHOICE HOT BIOPSY FORCEPS
K Number: K131991
·
Decision Oct 15, 2013
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
27
Review Days
109
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Basic Information
- Device Name
- ENDOCHOICE HOT BIOPSY FORCEPS
- K Number
- K131991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endochoice, Inc.
- Date Received
- June 28, 2013
- Decision Date
- October 15, 2013
- Product Code
- KGE
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
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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 |