# P020006: Enteryx Procedure Kit

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Apr 22, 2003 after 435 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
- Sep 23, 2005 · Not classified · Z-0040-06: Incorrect implantation may cause serious health complications

Source page: https://510kreport.com/device/P020006
Methodology: https://510kreport.com/methodology