Submission Details
| 510(k) Number | K090663 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2009 |
| Decision Date | April 09, 2009 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
K090663 - AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
(FDA 510(k) Clearance)
Apr 2009
Decision
28d
Days
Class 2
Risk
K090663 is an FDA 510(k) clearance for the AMS SPECTRA CONCEALABLE PENILE PROSTHESIS, a Prosthesis, Penile (Class II — Special Controls, product code FAE), submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 9, 2009, 28 days after receiving the submission on March 12, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.3630.
Device Classification
| Product Code | FAE — Prosthesis, Penile |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.3630 |
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