FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EC SINGLE USE, POLYPECTOMY SNARE
K Number: K123223
·
Decision Jan 10, 2013
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
62
Applicant Total
27
Review Days
87
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Basic Information
- Device Name
- EC SINGLE USE, POLYPECTOMY SNARE
- K Number
- K123223
- 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
- October 15, 2012
- Decision Date
- January 10, 2013
- Product Code
- FDI
- 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 |
|---|---|---|---|
| FDI | Snare, Flexible | FDA class 2 | Gastroenterology, Urology |
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| K152182 | Fuse Gastroscopy System | Dec 10, 2015 | Substantially Equivalent |
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| K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Jan 20, 2015 | Substantially Equivalent |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Oct 17, 2014 | Substantially Equivalent |