AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FDA 510(k) clearance K090663 · decided 2009-04-09
Clearance details
- K-number
- K090663
- Device name
- AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- Applicant
- American Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-12
- Decision date
- 2009-04-09
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FAE
- Device class
- 2
- Regulation number
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S002) | American Medical Systems, Inc. | 1998-12-23 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S001) | American Medical Systems, Inc. | 1998-01-09 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012) | American Medical Systems, Inc. | 1995-12-27 |