FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
AMS SPHINCTER 800 URINARY PROSTHESIS
K Number: K912934
·
Decision Mar 18, 1992
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
72
Review Days
257
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Basic Information
- Device Name
- AMS SPHINCTER 800 URINARY PROSTHESIS
- K Number
- K912934
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Medical Systems, Inc.
- Date Received
- July 5, 1991
- Decision Date
- March 18, 1992
- Product Code
- FAG
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FAG | Prosthesis, Urethral Sphincter | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAG), ordered by most recent decision date.
View allOther Clearances by American Medical Systems, Inc.
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| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE | Nov 26, 2008 | Substantially Equivalent |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | Oct 20, 2008 | Substantially Equivalent |