Cleared Traditional

K242318 - da Vinci SP Surgical System (SP1098)

K242318 is the FDA 510(k) clearance for da Vinci SP Surgical System (SP1098) by Intuitive Surgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code NAY) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K242318 · Intuitive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
2d faster than avg
Panel avg: 115d · 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 159
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K242318.
da Vinci Xi Surgical System (IS4000)
K242427 · Intuitive Surgical, Inc. · Apr 2025
da Vinci SP Advanced Access Port Kit (432701)
K243582 · Intuitive Surgical, Inc. · Feb 2025
da Vinci Surgical System (IS5000)
K243641 · Intuitive Surgical, Inc. · Dec 2024
da Vinci SP Instruments (SP1098)
K241814 · Intuitive Surgical, Inc. · Nov 2024
8mm SureForm 30 Curved-Tip Stapler
K241638 · Intuitive Surgical, Inc. · Sep 2024
Senhance Surgical System
K233866 · Asensus Surgical, Inc. · Jul 2024