FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOVA RECTAL STIMULATON ELECTRODE
K Number: K954272
·
Decision Apr 15, 1996
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
60
Review Days
216
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Basic Information
- Device Name
- INNOVA RECTAL STIMULATON ELECTRODE
- K Number
- K954272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empi
- Date Received
- September 12, 1995
- Decision Date
- April 15, 1996
- Product Code
- KPI
- 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 |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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