Cleared Traditional

da Vinci Xi Surgical System (K170713) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K170713 · Intuitive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
96d
Days
Class 2
Risk

K170713 is an FDA 510(k) clearance for the da Vinci Xi Surgical System. 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 96 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. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K170713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2017
Decision Date June 13, 2017
Days to Decision 96 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02684448 Completed Observational Industry-sponsored

Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair

A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes in Inguinal Hernia Repair

1258
Patients (actual)
2
Sites
Condition studied Hernia, Inguinal; Hernia, Inguinal, Direct; Hernia, Inguinal, Indirect
Eligibility All sexes · 18 Years+
Sponsor Intuitive Surgical (industry)
Started 2016-01-01 → Primary completion 2016-06-01 → Completed 2017-01-01
Primary outcome
Number of complications observed intraoperatively through 30-days
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K170713.
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
K170644 · Intuitive Surgical, Inc. · Sep 2017
da Vinci Xi EndoWrist Instruments and Accessories
K170645 · Intuitive Surgical, Inc. · Sep 2017
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
K171699 · Intuitive Surgical, Inc. · Jul 2017
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
K171426 · Intuitive Surgical, Inc. · Jun 2017
EndoWrist Stapler 45 System and Stapler 45 Reloads
K171388 · Intuitive Surgical, Inc. · May 2017
da Vinci X Surgical System
K171294 · Intuitive Surgical, Inc. · May 2017