# K183619: Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 16, 2019 after 111 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. The FDA summary names no predicate by number.

Source page: https://510kreport.com/device/K183619
Methodology: https://510kreport.com/methodology