Cleared Special

Senhance Surgical System (K183098) - FDA 510(k) Clearance

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

K183098 · Transenterix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
29d
Days
Class 2
Risk

K183098 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 December 6, 2018 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.

View all Transenterix, Inc. devices

Submission Details

510(k) Number K183098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2018
Decision Date December 06, 2018
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.

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 K183098.
SureForm 45, SureForm 45 Reloads
K183224 · Intuitive Surgical · Jan 2019
Senhance Ultrasonic System
K182421 · Transenterix, Inc. · Jan 2019
Intuitive Surgical Vessel Sealer Extend
K183107 · Intuitive Surgical, Inc. · Dec 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K182140 · Intuitive Surgical, Inc. · Oct 2018
Senhance Surgical System
K181517 · Transenterix, Inc. · Oct 2018
SOLOASSIST II
K171947 · Aktormed GmbH · Sep 2018