# K071907: Vcare Retractor/Elevator

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Oct 5, 2007 after 87 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955446 (1996). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955446: Conmed Vcare Retractor/Elevator, Conmedcorp (1996) Summary page 1.

## Most influential descendants
- K142716: VCARE (2015), 1 descendant of its own
- K142164: Manipulator; Manipulator Pro (2014), 1 descendant of its own
- K131781: Clearview Total (2014), 1 descendant of its own
- K220202: Uterine ElevatOR PRO with OccludOR Balloon (2022), 0 descendants of its own
- K172846: Uterine Manipulator (2018), 0 descendants of its own

## Recalls of this device
- Feb 2, 2011 · Not classified · Z-1520-2011: Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 a
- Sep 8, 2008 · Not classified · Z-0175-2009: The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retaine
- Sep 8, 2008 · Not classified · Z-0176-2009: The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retaine
- Sep 8, 2008 · Not classified · Z-0177-2009: The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retaine

## Indications for use
The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases 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 by sealing the vagina once colpotomy is performed.

Source page: https://510kreport.com/device/K071907
Methodology: https://510kreport.com/methodology