FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED STONE RETRIEVAL BASKETS
K Number: K012581
·
Decision Feb 14, 2002
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
51
Applicant Total
64
Review Days
189
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Basic Information
- Device Name
- REPROCESSED STONE RETRIEVAL BASKETS
- K Number
- K012581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterilmed, Inc.
- Date Received
- August 9, 2001
- Decision Date
- February 14, 2002
- Product Code
- FFL
- 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 |
|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | FDA class 2 | Gastroenterology, Urology |
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