# K932115: Rowden Uterine Manipulator Injector and Rumi

- Pathway: 510(k) (Traditional)
- Applicant: Blairden Precision Instruments, Inc.
- Decided: Jun 24, 1994 after 417 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 2 (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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 31, 2012 · Class II · Z-0439-2013: Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of 
- Oct 31, 2012 · Class II · Z-0440-2013: Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of 

Source page: https://510kreport.com/device/K932115
Methodology: https://510kreport.com/methodology