# K163214: Unicare System, Unicare Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Clearpath Surgical, Inc.
- Decided: Feb 7, 2017 after 83 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- 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: 2 generations back to K955446 (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)
- K071907: Vcare Retractor/Elevator, Conmed Corporation (2007) Summary page 4.

## Indications for use
The Unicare System is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy. The Unicare Manipulator is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.

Source page: https://510kreport.com/device/K163214
Methodology: https://510kreport.com/methodology