# P990002: Femsoft Urethral Insert

- Pathway: PMA
- Applicant: Rochester Medical Corp.
- Decided: Sep 30, 1999 after 254 days
- Product code: OCK (Transurethral Occlusion Insert, Urinary Incontinence-Control, Female)
- Device class: 3
- Recalls of this device: 8 (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
- Apr 27, 2010 · Not classified · Z-1910-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1908-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1907-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1906-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1909-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1913-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1911-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal
- Apr 27, 2010 · Not classified · Z-1912-2010: Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a smal

Source page: https://510kreport.com/device/P990002
Methodology: https://510kreport.com/methodology