# K912935: Ams Malleable 600 and 600M Penile Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Mar 18, 1992 after 257 days
- Product code: FAE (Prosthesis, Penile)
- Device class: 2
- Regulation: 21 CFR 876.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082006: Ams Spectra Concealable Penile Prosthesis (2008), 1 descendant of its own
- K090663: Ams Spectra Concealable Penile Prosthesis (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K912935
Methodology: https://510kreport.com/methodology