K232610 is an FDA 510(k) clearance for the da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with.... Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.
Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 14, 2024 after a review of 199 days - an extended review cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
View all Intuitive Surgical, Inc. devices
NCT05682742
Active not recruiting
Interventional
Industry-sponsored
Clinical Investigation of the da Vinci Surgical System
A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System
| Condition studied |
Thymoma; Mediastinal Tumor; Gynecologic Disease; Gynecologic Cancer; Pelvic Organ Prolapse; Prostate Disease; Prostate Cancer; Inguinal Hernia; Ventral Hernia; Obesity, Morbid |
| Study design |
Single group |
| Eligibility |
All sexes
· 21 Years+
|
| Sponsor |
Intuitive Surgical
(industry)
|
Started 2022-12-12
→
Primary completion 2023-05-24
→
Completed 2028-08-31
Primary outcome
Incidence of conversion
Secondary outcome
Incidence of adverse events
View full study on ClinicalTrials.gov