DeviceClearance

da Vinci 5 Handheld Camera Head (470080) +4 more— 510(k) K262455

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K262455 for da Vinci 5 Handheld Camera Head (470080) +4 more, Substantially Equivalent on 2026-10-14. Applicant: Intuitive Surgical, Inc.. Device class: 2.

Clearance details

Device name as filed
da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System
Applicant
Intuitive Surgical, Inc.
Product code
Product code GCJ
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GCJ

view all

More clearances from Intuitive Surgical, Inc.

view all

Adverse events under product code GCJ

product code GCJ
Death
39
Injury
1,638
Malfunction
28,216
Other
11
Total
29,904

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.