FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
K Number: K062475
·
Decision May 9, 2007
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
4
Review Days
258
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Basic Information
- Device Name
- LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
- K Number
- K062475
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Laryngeal Mask Co., Ltd.
- Date Received
- August 24, 2006
- Decision Date
- May 9, 2007
- Product Code
- FFK
- 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 |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | FDA class 2 | Gastroenterology, Urology |
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