Cleared Special

K150284 - IS4000 da Vinci EndoWrist Instruments

K150284 is the FDA 510(k) clearance for IS4000 da Vinci EndoWrist Instruments by Intuitive Surgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code NAY) cleared through the Special 510(k) pathway after a 99-day FDA review.

K150284 · Intuitive Surgical, Inc. · General & Plastic Surgery device
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May 2015
Decision
99d
Days
Class 2
Risk

K150284 is an FDA 510(k) clearance for the IS4000 da Vinci EndoWrist Instruments. 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 May 15, 2015 after a review of 99 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K150284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2015
Decision Date May 15, 2015
Days to Decision 99 days
Submission Type Special
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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

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 158
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K150284.
da Vinci Single-Site Instrument and Accessories
K152448 · Intuitive Surgical, Inc. · Mar 2016
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
K152421 · Intuitive Surgical, Inc. · Mar 2016
da Vinci Xi Surgical System
K151794 · Intuitive Surgical, Inc. · Jan 2016
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
K150837 · Intuitive Surgical, Inc. · Apr 2015
IS4000 8mm Harmonic ACE Curved Shears
K143132 · Intuitive Surgical, Inc. · Apr 2015
12 mm Endoscopes and Accessories
K142683 · Intuitive Surgical, Inc. · Dec 2014