FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOFILAMENT POLYPECTOMY SNARE
K Number: K140763
·
Decision Apr 24, 2014
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
61
Applicant Total
1
Review Days
28
Basic Information
- Device Name
- MONOFILAMENT POLYPECTOMY SNARE
- K Number
- K140763
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- UNITED STATES ENDOSCOPY
- Date Received
- March 27, 2014
- Decision Date
- April 24, 2014
- 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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