FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETERAL ACCESS SHEATH SET - NEW MODELS
K Number: K993650
·
Decision Dec 28, 1999
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
58
Review Days
60
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Basic Information
- Device Name
- URETERAL ACCESS SHEATH SET - NEW MODELS
- K Number
- K993650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Resources
- Date Received
- October 29, 1999
- Decision Date
- December 28, 1999
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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