Cleared Traditional

K242318 - da Vinci SP Surgical System (SP1098) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K242318 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Nov 2024
Decision
113d
Days
Class 2
Risk

K242318 is an FDA 510(k) clearance for the da Vinci SP Surgical System (SP1098). Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Suunyvale, US). The FDA issued a Cleared decision on November 26, 2024 after a review of 113 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K242318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 05, 2024
Decision Date November 26, 2024
Days to Decision 113 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
1d faster than avg
Panel avg: 114d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04403022 Active not recruiting Interventional Industry-sponsored

da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

60
Patients (actual)
9
Sites
Other
Purpose
Open label
Masking
Condition studied Colorectal Cancer; Benign or Malignant Rectal or Colon Tumors
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Madhu L Gorrepati
Sponsor Intuitive Surgical (industry)
Started 2021-06-03 → Primary completion 2023-09-30 → Completed 2028-11-30
Primary outcome
Performance
View full study on ClinicalTrials.gov

Regulatory Peers - NAY System, Surgical, Computer Controlled Instrument

All 161
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K242318.
da Vinci Force Feedback Instruments
K253986 · Intuitive Surgical, Inc. · Mar 2026
da Vinci Surgical System (IS5000)
K251739 · Intuitive Surgical, Inc. · Jan 2026
da Vinci SP Surgical System (SP1098)
K253556 · Intuitive Surgical, Inc. · Jan 2026
da Vinci SP Surgical System (SP1098)
K252675 · Intuitive Surgical, Inc. · Dec 2025
da Vinci SP Surgical System (SP1098)
K252069 · Intuitive Surgical, Inc. · Dec 2025
da Vinci SP Surgical System (SP1098)
K251426 · Intuitive Surgical, Inc. · Oct 2025