# K082939: Cook Fetal Membrane Manipulator, Model -FMM-122400

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Sep 3, 2009 after 336 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K941458 (1995). 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)
- K941458: Uterine Manipulator/Injector with Spring, Zinnanti Surgical Instruments, Inc. (1995) Summary page 1.

## Indications for use
The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.

Source page: https://510kreport.com/device/K082939
Methodology: https://510kreport.com/methodology