Cleared Special

Senhance Surgical System (K192877) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192877 · Transenterix, Inc. · General & Plastic Surgery device
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Nov 2019
Decision
45d
Days
Class 2
Risk

K192877 is an FDA 510(k) clearance for the Senhance Surgical 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 November 22, 2019 after a review of 45 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.

View all Transenterix, Inc. devices

Submission Details

510(k) Number K192877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2019
Decision Date November 22, 2019
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 K192877.
da Vinci X and Xi Surgical System
K183086 · Intuitive Surgical, Inc. · Mar 2020
Senhance Surgical System
K200049 · Transenterix, Inc. · Mar 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K191529 · Intuitive Surgical · Feb 2020
E-100 Electrosurgical Generator, SynchroSeal
K191280 · Intuitive Surgical, Inc. · Nov 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
K191736 · Intuitive Surgical · Jul 2019
SureForm 45 Curved Tip, SureForm 45 Gray Reload
K190999 · Intuitive Surgical, Inc. · Jul 2019