510(k) clearance
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
- 510(k) number
- K262455
- Applicant
- Intuitive Surgical, Inc.
- Decision date
- Oct 14, 2026
- Date received
- Jul 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GCJ
- Device type
- Laparoscope, General & Plastic Surgery
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Sunnyvale, CA, US