FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
K Number: K971498
·
Decision May 5, 1997
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
2
Applicant Total
58
Review Days
10
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Basic Information
- Device Name
- APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
- K Number
- K971498
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Resources
- Date Received
- April 25, 1997
- Decision Date
- May 5, 1997
- Product Code
- EZB
- 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 |
|---|---|---|---|
| EZB | Stylet For Catheter, Gastro-Urology | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZB), ordered by most recent decision date.
CORE AND COIL ASSEMBLY GUIDEWIRE
FDA 510(k)
FDA Class 1
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FDA 510(k)
FDA Class 1
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