# K051160: Manipuseal

- Pathway: 510(k) (Traditional)
- Applicant: Insitu Systems
- Decided: Sep 2, 2005 after 120 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010056: Uterine Manipulator Injector Cannula, Sterile, Model R 57-450, A & A Medical, Inc. (2001) Summary page 1.
- K954311: Koh Colpotomizer System, CooperSurgical, Inc. (1996) Summary page 1.

## Indications for use
The Manipuseal device is indicated for use in all laparoscopic surgical procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove intraperitoneal tissue through the vagina by use of a colpotomy or culdotomy incision.

Source page: https://510kreport.com/device/K051160
Methodology: https://510kreport.com/methodology