# K071488: Realhand High Dexterity (HD) Instruments

- Pathway: 510(k) (Special)
- Applicant: Novare Surgical Systems, Inc.
- Decided: Jun 29, 2007 after 30 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: 3 generations back to K910831 (1991). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043541: Endolink True Movement System, Novare Surgical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K072715: Realhand High Dexterity Instruments (2007), 1 descendant of its own
- K212736: Canady Flex RoboWrist (2022), 0 descendants of its own

## Indications for use
The RealHandTM High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.

Source page: https://510kreport.com/device/K071488
Methodology: https://510kreport.com/methodology