Cleared Special

K171426 - da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree

K171426 is an FDA 510(k) clearance for da Vinci Xi 8mm Endoscope, 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 29-day FDA review.

K171426 · 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
Jun 2017
Decision
29d
Days
Class 2
Risk

K171426 is an FDA 510(k) clearance for the da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree. 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 June 13, 2017 after a review of 29 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. 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. Low regulatory complexity profile. 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 - K171426

510(k) Number K171426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date June 13, 2017
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K171426.
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K170645 · Intuitive Surgical, Inc. · Sep 2017
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K171294 · Intuitive Surgical, Inc. · May 2017
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K170865 · Intuitive Surgical, Inc. · Apr 2017