# K992027: Koninckx Uterine Manipulator, Keckstein-Schiff Uterine Manipulator, Clermont Uterine Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Sep 9, 1999 after 85 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- 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. The FDA summary names no predicate by number.

## Indications for use
The KSEA Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic assisted vaginal hysterectomy (LAVH).

Source page: https://510kreport.com/device/K992027
Methodology: https://510kreport.com/methodology