Cleared Traditional

da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) (K223080) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223080 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Nov 2022
Decision
53d
Days
Class 2
Risk

K223080 is an FDA 510(k) clearance for the da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000). 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 November 22, 2022 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K223080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date November 22, 2022
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAY System, Surgical, Computer Controlled Instrument
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NAY System, Surgical, Computer Controlled Instrument

All 158
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K223080.
Da Vinci SP Surgical System (SP1098)
K230033 · Intuitive Surgical, Inc. · Apr 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
K222839 · Intuitive Surgical, Inc. · Mar 2023
Senhance Surgical System
K223095 · Asensus Surgical, Inc. · Mar 2023
da Vinci Firefly Imaging System
K222827 · Intuitive Surgical, Inc. · Oct 2022
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
K214095 · Intuitive Surgical, Inc. · Aug 2022
Senhance Surgical System
K220889 · Asensus Surgical, Inc. · May 2022