# K072715: Realhand High Dexterity Instruments

- Pathway: 510(k) (Special)
- Applicant: Novare Surgical Systems, Inc.
- Decided: Oct 16, 2007 after 21 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: 4 generations back to K910831 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K071488: Realhand High Dexterity (HD) Instruments, Novare Surgical Systems, Inc. (2007) Summary page 2.
- K043541: Endolink True Movement System, Novare Surgical Systems, Inc. (2005) Summary page 2.
- K033249: Pajunk Modular Handle Instruments, Pajunk GmbH (2004) Summary page 2.
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 2.

## Most influential descendants
- K212736: Canady Flex RoboWrist (2022), 0 descendants of its own

## Indications for use
The RealHand Tm High Dexterity (HID) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

Source page: https://510kreport.com/device/K072715
Methodology: https://510kreport.com/methodology