# K912344: Modified Duraphase (TM) Implanted Penile Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Dacomed Corp.
- Decided: Oct 11, 1991 after 136 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

Source page: https://510kreport.com/device/K912344
Methodology: https://510kreport.com/methodology