Cleared Traditional

K171120 - Senhance Surgical Robotic System

K171120 is an FDA 510(k) clearance for Senhance Surgical Robotic System, manufactured by Transenterix, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NAY cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K171120 · Transenterix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
182d
Days
Class 2
Risk

K171120 is an FDA 510(k) clearance for the Senhance Surgical Robotic System. Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.

Submitted by Transenterix, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 13, 2017 after a review of 182 days - an extended review 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. 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 Transenterix, Inc. devices

FDA 510(k) Submission Details - K171120

510(k) Number K171120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date October 13, 2017
Days to Decision 182 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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

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

Clinical Evidence

ClinicalTrials.gov
NCT03093675 Completed Interventional Industry-sponsored

Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

150
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Adnexal Diseases; Uterine Diseases
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Giovanni Scambia, Professor
Sponsor SOFAR S.p.A. (industry)
Started 2013-10-23 → Primary completion 2014-12-09
Primary outcome
Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases
Secondary outcome
Robotic assisted surgery learning curve assessed through the reduction of procedure times
Study completed - no results published. This trial concluded in 2014 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 165
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to K171120.
da Vinci Xi Surgical System, da Vinci X Surgical System
K173842 · Intuitive Surgical, Inc. · Apr 2018
8mm Monopolar Curved Scissors
K180033 · Intuitive Surgical, Inc. · Apr 2018
da Vinci Xi Surgical System
K172643 · Intuitive Surgical, Inc. · Jan 2018
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
K170641 · Intuitive Surgical, Inc. · Sep 2017
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
K170879 · Intuitive Surgical, Inc. · Sep 2017
da Vinci Xi Surgical System
K171632 · Intuitive Surgical, Inc. · Sep 2017