Cleared Traditional

K182371 - da Vinci SP Surgical System

K182371 is the FDA 510(k) clearance for da Vinci SP Surgical System by Intuitive Surgical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code NAY) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

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 159
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K182371.
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
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Senhance Surgical System
K191482 · Transenterix, Inc. · Jul 2019
SureForm 45, SureForm 45 Reloads
K183224 · Intuitive Surgical · Jan 2019
Senhance Ultrasonic System
K182421 · Transenterix, Inc. · Jan 2019
Intuitive Surgical Vessel Sealer Extend
K183107 · Intuitive Surgical, Inc. · Dec 2018