Cleared Traditional

da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K182371) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182371 · Intuitive Surgical, Inc. · Ear, Nose, Throat device
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Mar 2019
Decision
195d
Days
Class 2
Risk

K182371 is an FDA 510(k) clearance for the da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories. 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, 2019 after a review of 195 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 876.1500 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K182371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 31, 2018
Decision Date March 14, 2019
Days to Decision 195 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 89d · This submission: 195d
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - NAY System, Surgical, Computer Controlled Instrument

All 163
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K182371.
da Vinci Firefly Imaging System
K260695 · Intuitive Surgical · May 2026
Senhance Ultrasonic System
K254192 · Asensus Surgical · May 2026
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