# P170023: Bulkamid Urethral Bulking System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: Jan 28, 2020 after 911 days
- Product code: LNM (Agent, Bulking, Injectable For Gastro-Urology Use)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 3, 2021 · Class II · Z-2077-2021: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized

Source page: https://510kreport.com/device/P170023
Methodology: https://510kreport.com/methodology