Gastroenterology-Urology · 510(k) · 2026
Instrument Exit Point on Touch Surgery Aide
Covidien, LLC. Cleared by FDA on 4 June 2026 under submission K253984, product code SFE (endoscopic video imaging system / software component for real time video augmentation). What FDA's record says, in FDA's words.
Device record · K253984
- Device. Instrument Exit Point on Touch Surgery AideDEVICE
- Company. Covidien, LLCCOMPANY
- Decision. 4 June 2026, 510(k), substantially equivalent (traditional review); received 12 December 2025DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. SFE, Endoscopic Video Imaging System / Software Component For Real Time Video AugmentationCODE
- Regulation. 21 CFR 876.1500, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Instrument Exit Point application is an AI - enabled device software function that is indicated for use during robotic-assisted surgery with Hugo RAS to detect when the supported instruments leave the field-of-view. The system is intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view. Brief Description Instrument Exit Point provides real -time notification to the surgeon when and where a supported Hugo RAS energy instrument(s) has left the surgeon’s field -of-view, with information displayed as an overlay on the Touch Surgery Aide monitor. The HSS provides for visualization of real-time tissue oxygenation saturation (StO2) information alongside conventional red - green-blue (RGB) visualization. Mechanism of Action Software analysis of white light endoscopic visualization Software analysis of conventional RGB endoscopic visualization Development Method Machine Learning methodology used to develop software algorithm responsible for detecting the supported instrument’s position . Once developed, this software algorithm is fixed and static and added to Touch Surgery Aide platform software. Machine Learning methodology used to develop software algorithm responsible for extraction of advanced optical properties of observed tissues alongside conventional red - green-blue (RGB) visualization. Once developed, this software algorithm is fixed and static and added to computational […]
The product code's definition, from FDA's classification record. To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedendoscopy
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SFE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SFE, in Gastroenterology-Urology, from Covidien, LLC, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.