Intuitive Surgical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: da Vinci Xi Surgical System (IS4000), da Vinci 5 Handheld Camera Head (470080), da Vinci Surgical System, Model IS5000
182
Total
162
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intuitive Surgical, Inc. General & Plastic Surgery ✕
158 devices
Cleared
Oct 30, 2026
da Vinci Xi Surgical System (IS4000)
General & Plastic Surgery
30d
Cleared
Oct 14, 2026
da Vinci 5 Handheld Camera Head (470080)
General & Plastic Surgery
89d
Cleared
Sep 08, 2026
da Vinci Surgical System, Model IS5000
General & Plastic Surgery
99d
Cleared
Jul 31, 2026
da Vinci Surgical System, Model IS5000
General & Plastic Surgery
60d
Cleared
Jul 14, 2026
Universal Seal (5-12 mm)
General & Plastic Surgery
89d
Cleared
Mar 11, 2026
da Vinci Force Feedback Instruments
General & Plastic Surgery
89d
Cleared
Feb 24, 2026
Universal Seal (5-12 mm)
General & Plastic Surgery
74d
Cleared
Jan 16, 2026
da Vinci Surgical System (IS5000)
General & Plastic Surgery
224d
Cleared
Jan 16, 2026
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
63d
Cleared
Dec 15, 2025
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
112d
Cleared
Dec 02, 2025
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
154d
Cleared
Oct 03, 2025
da Vinci SP Surgical System (SP1098)
General & Plastic Surgery
148d
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