FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
K Number: K910214
·
Decision Apr 25, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
31
Applicant Total
3
Review Days
98
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Basic Information
- Device Name
- AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
- K Number
- K910214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.3630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Medical Corp.
- Date Received
- January 17, 1991
- Decision Date
- April 25, 1991
- Product Code
- FAE
- 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 |
|---|---|---|---|
| FAE | Prosthesis, Penile | FDA class 2 | Gastroenterology, Urology |
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