Cleared Traditional

K243641 - da Vinci Surgical System (IS5000)

K243641 is the FDA 510(k) clearance for da Vinci Surgical System (IS5000) 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 20-day FDA review.

K243641 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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Dec 2024
Decision
20d
Days
Class 2
Risk

K243641 is an FDA 510(k) clearance for the da Vinci Surgical System (IS5000). 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 December 16, 2024 after a review of 20 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 K243641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date December 16, 2024
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 159
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K243641.
da Vinci SP Surgical System (SP1098)
K243714 · Intuitive Surgical, Inc. · Apr 2025
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 SP Surgical System (SP1098)
K242318 · Intuitive Surgical, Inc. · Nov 2024
da Vinci SP Instruments (SP1098)
K241814 · Intuitive Surgical, Inc. · Nov 2024
8mm SureForm 30 Curved-Tip Stapler
K241638 · Intuitive Surgical, Inc. · Sep 2024