# K131781: Clearview Total

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, LLC
- Decided: May 28, 2014 after 345 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955446 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940681: Clearview Uterine Manipulator, Clinical Innovations, Inc. (1994) Summary page 1.
- K071907: Vcare Retractor/Elevator, Conmed Corporation (2007) Summary page 1.
- K954311: Koh Colpotomizer System, CooperSurgical, Inc. (1996) Summary page 1.

## Most influential descendants
- K172846: Uterine Manipulator (2018), 0 descendants of its own

## Recalls of this device
- May 30, 2019 · Class II · Z-2118-2020: An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surger

## Indications for use
The ClearView Total is intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitoneal tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

Source page: https://510kreport.com/device/K131781
Methodology: https://510kreport.com/methodology