Cleared Special

K150284 - IS4000 da Vinci EndoWrist Instruments

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

K150284 · Intuitive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K150284

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.

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. 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 165
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
K150284 · IS4000 da Vinci EndoWrist Instruments
Download PDF FDA Summary Intuitive Surgical, I…