Cleared Traditional

da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)

K240852 · Intuitive Surgical, Inc. · General & Plastic Surgery

Jun 2025

Decision

440d

Days

Class 2

Risk

About This 510(k) Submission

K240852 is an FDA 510(k) clearance for the da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000), a System, Surgical, Computer Controlled Instrument (Class II — Special Controls, product code NAY), submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 11, 2025, 440 days after receiving the submission on March 28, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K240852 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2024
Decision Date	June 11, 2025
Days to Decision	440 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	NAY — System, Surgical, Computer Controlled Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).