FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECT-SNARE
K Number: K942110
·
Decision Oct 13, 1994
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
62
Applicant Total
37
Review Days
164
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Basic Information
- Device Name
- INJECT-SNARE
- K Number
- K942110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endovations
- Date Received
- May 2, 1994
- Decision Date
- October 13, 1994
- 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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