Cleared Traditional

Senhance Surgical System (K202166) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202166 · Transenterix, Inc. · General & Plastic Surgery device
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Mar 2021
Decision
211d
Days
Class 2
Risk

K202166 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 March 2, 2021 after a review of 211 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

Submission Details

510(k) Number K202166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2020
Decision Date March 02, 2021
Days to Decision 211 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
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K202166.
da Vinci SP Surgical System (SP1098)
K211316 · Intuitive Surgical, Inc. · Jul 2021
da Vinci SP Surgical System (SP1098)
K211595 · Intuitive Surgical, Inc. · Jun 2021
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K210918 · Intuitive Surgical, Inc. · Apr 2021
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
K203632 · Intuitive Surgical, Inc. · Feb 2021
SoloAsisst II, Voice Control
K200473 · Aktormed GmbH · Dec 2020
Da Vinci SP Surgical System
K202968 · Intuitive Surgical, Inc. · Dec 2020