FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
K Number: DEN000002
·
Decision Feb 9, 2000
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
7
Applicant Total
4
Review Days
13
Basic Information
- Device Name
- UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
- K Number
- DEN000002
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 876.5310
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- UROSURGE, INC.
- Date Received
- January 27, 2000
- Decision Date
- February 9, 2000
- Product Code
- NAM
- 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 |
|---|---|---|---|
| NAM | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | FDA class 2 | Gastroenterology, Urology |
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