FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RSH BILIARY STONE REMOVAL DEVICE
K Number: K131642
·
Decision Aug 7, 2013
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
37
Applicant Total
1
Review Days
64
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Basic Information
- Device Name
- RSH BILIARY STONE REMOVAL DEVICE
- K Number
- K131642
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rsh, LLC
- Date Received
- June 4, 2013
- Decision Date
- August 7, 2013
- 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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