# K111014: Lsi Solutions Fornisee System Uterine Manipulator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lsi Solutions, Inc.
- Decided: Jul 13, 2012 after 459 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954311 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954311: Koh Colpotomizer System, CooperSurgical, Inc. (1996)

## Indications for use
The LSI Solutions® ForniSeeTM System is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.

Source page: https://510kreport.com/device/K111014
Methodology: https://510kreport.com/methodology