# K954311: Koh Colpotomizer System

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Nov 19, 1996 after 431 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- 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.
13 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lubke Uterine Vacuum Cannula: named in the summary without a submission number
- (no number) SEMM Uterine Vacuum Cannula: named in the summary without a submission number
- (no number) Milex Inflato Ball: named in the summary without a submission number

## Most influential descendants
- K051594: Mccartney Access Tube (2005), 3 descendants of its own
- K143308: GelPOINT Transvaginal Access Platform (2015), 2 descendants of its own
- K143650: CooperSurgical Advincula Delineator Uterine Manipulator (2015), 2 descendants of its own
- K191294: Transvaginal Access Platform (2019), 1 descendant of its own
- K180429: Advincula Delineator Uterine Manipulator (2018), 1 descendant of its own

## Recalls of this device
- Apr 23, 2021 · Class II · Z-1686-2021: The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
- Sep 4, 2018 · Class II · Z-0098-2019: The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

## Indications for use
The Koh Colpotomizer™ System, comprised of the Koh Cup™ Vaginal Fornices Delineator and Colpo-Pneumo Occluder, are accessories to the RUMI uterine manipulator, K932115. These accessories are designed to attach to the RUMI uterine manipulator device and are intended to be used by the surgeon as an anatomical marker to locate the position of the vaginal fornices as viewed through uterine tissue from within the abdominal cavity (intracorporeal), and also to maintain pneumoperitoneum during laparoscopic surgical procedures in which a colpotomy or culdotomy incision is made. The Koh Colpotomizer™ System is used in conjunction with the RUMI uterine manipulator device.

Source page: https://510kreport.com/device/K954311
Methodology: https://510kreport.com/methodology