# K043541: Endolink True Movement System

- Pathway: 510(k) (Traditional)
- Applicant: Novare Surgical Systems, Inc.
- Decided: Mar 10, 2005 after 78 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K910831 (1991). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K972510: Pivotal Scissor, Urohealth Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K071488: Realhand High Dexterity (HD) Instruments (2007), 2 descendants of its own
- K072715: Realhand High Dexterity Instruments (2007), 1 descendant of its own
- K212736: Canady Flex RoboWrist (2022), 0 descendants of its own
- K072811: Marionette SA, Model 001 001 & 001 002 (2008), 0 descendants of its own

## Indications for use
The EndolinkTM True Movement SystemTM is intended for grasping, mobilization, dissection and transection of tissue under direct and endoscopic visualization.

Source page: https://510kreport.com/device/K043541
Methodology: https://510kreport.com/methodology