# K041338: Medtronic Octopus TE Stabilizer & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 19, 2004 after 60 days
- Product code: MWS (Stabilizer, Heart)
- Device class: 1
- Regulation: 21 CFR 870.4500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964445 (1997). 2 ancestors in all.
157 later devices descend from it; 2 cite it directly.
1 of 160 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006), Dlp, Inc. (1997) Summary page 1.
- K992833: Vacuum Assist Stabilizer, Cardio Thoracic Systems (1999) Summary page 1.

## Most influential descendants
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182 (2006), 155 descendants of its own
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 (2009), 153 descendants of its own
- K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals (2012), 148 descendants of its own
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories (2014), 124 descendants of its own
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own

## Indications for use
The Stabilizer is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

Source page: https://510kreport.com/device/K041338
Methodology: https://510kreport.com/methodology