FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
K Number: K001563
·
Decision Nov 22, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
18
Applicant Total
1
Review Days
187
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Basic Information
- Device Name
- SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
- K Number
- K001563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scion Cardiovascular, Inc.
- Date Received
- May 19, 2000
- Decision Date
- November 22, 2000
- Product Code
- FGO
- 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 |
|---|---|---|---|
| FGO | Dislodger, Stone, Flexible | FDA class 2 | Gastroenterology, Urology |
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