# K253984: Instrument Exit Point on Touch Surgery™ Aide

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jun 4, 2026 after 174 days
- Product code: SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931154 (1993). 40 ancestors in all.
No later device cites it as a predicate yet.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250268: HyperSnap Surgical System (HSS), Hypervision Surgical (2025) Summary page 5.

## Indications for use
The Instrument exit point application is indicated for use as an adjunct during surgical procedures performed using the Hugo™ Robotic-Assisted Surgery (RAS) system, in accordance with the FDA-cleared indications for use of the Hugo RAS system. The Instrument exit point application does not expand, modify, or replace the indications for use of the Hugo RAS system; refer to the Hugo™ RAS labeling for the applicable indications for use.

Source page: https://510kreport.com/device/K253984
Methodology: https://510kreport.com/methodology