FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Stone Extraction basket
K Number: K201509
·
Decision Dec 16, 2020
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
36
Applicant Total
12
Review Days
194
Basic Information
- Device Name
- Disposable Stone Extraction basket
- K Number
- K201509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Date Received
- June 5, 2020
- Decision Date
- December 16, 2020
- Product Code
- LQR
- 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 |
|---|---|---|---|
| LQR | Dislodger, Stone, Biliary | FDA class 2 | Gastroenterology, Urology |
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