FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETERAL STONE DISLODGER
K Number: K851922
·
Decision Aug 2, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
51
Applicant Total
4
Review Days
92
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Basic Information
- Device Name
- URETERAL STONE DISLODGER
- K Number
- K851922
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Inter-Med Corp.
- Date Received
- May 2, 1985
- Decision Date
- August 2, 1985
- Product Code
- FFL
- 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 |
|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | FDA class 2 | Gastroenterology, Urology |
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