FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
K Number: K860863
·
Decision May 15, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
1
Review Days
69
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Basic Information
- Device Name
- ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
- K Number
- K860863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- George Percy Mcgown
- Date Received
- March 7, 1986
- Decision Date
- May 15, 1986
- Product Code
- LQC
- 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 |
|---|---|---|---|
| LQC | Lithotriptor, Biliary Mechanical | FDA class 2 | Gastroenterology, Urology |
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