# K955446: Conmed Vcare Retractor/Elevator

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Jun 18, 1996 after 202 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071907: Vcare Retractor/Elevator (2007), 7 descendants of its own
- 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
- K093556: Vcare DX (2010), 1 descendant of its own

## Recalls of this device
- Sep 8, 2008 · Not classified · Z-0178-2009: 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-0180-2009: 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-0179-2009: 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

Source page: https://510kreport.com/device/K955446
Methodology: https://510kreport.com/methodology