Cleared Traditional

K232610 - da Vinci Surgical System Model IS5000

K232610 is an FDA 510(k) clearance for da Vinci Surgical System Model IS5000, manufactured by Intuitive Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NAY cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K232610 · Intuitive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
199d
Days
Class 2
Risk

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

FDA 510(k) Submission Details - K232610

510(k) Number K232610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2023
Decision Date March 14, 2024
Days to Decision 199 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
84d slower than avg
Panel avg: 115d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

NAY Device Classification - Class 2, Special Controls

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
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

53
Patients (actual)
4
Sites
Other
Purpose
Open label
Masking
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

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 K232610.
da Vinci Surgical System (IS5000)
K241284 · Intuitive Surgical, Inc. · Jul 2024
da Vinci SP Surgical System (SP1098)
K232773 · Intuitive Surgical, Inc. · Jun 2024
da Vinci Xi Surgical System (IS4000)
K240723 · Intuitive Surgical · May 2024
da Vinci SP Surgical System
K231798 · Intuitive Surgical, Inc. · Nov 2023
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K231224 · Intuitive Surgical, Inc. · May 2023
Da Vinci SP Surgical System (SP1098)
K230033 · Intuitive Surgical, Inc. · Apr 2023