# K191043: da Vinci Handheld Camera

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jun 6, 2019 after 48 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001666 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080155: Modification to:Intuitive Surgical Stereo View Endoscopic System, Intuitive Surgical, Inc. (2008) Summary page 4.

## Most influential descendants
- K241913: da Vinci Handheld Camera (2024), 0 descendants of its own

## Recalls of this device
- Dec 19, 2019 · Class II · Z-2329-2020: Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and r

## Indications for use
The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.

Source page: https://510kreport.com/device/K191043
Methodology: https://510kreport.com/methodology