# K964445: Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Jan 30, 1997 after 85 days
- Product code: DWS (Instruments, Surgical, Cardiovascular)
- 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
No predicates in its family tree.
161 later devices descend from it; 4 cite it directly.
1 of 162 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer: named in the summary without a submission number
- (no number) DLP Cardiac Suction Tube: named in the summary without a submission number

## Most influential descendants
- K992833: Vacuum Assist Stabilizer (1999), 159 descendants of its own
- K041338: Medtronic Octopus TE Stabilizer & Accessories (2004), 157 descendants of its own
- 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

## Indications for use
Both are intended for use during coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

Source page: https://510kreport.com/device/K964445
Methodology: https://510kreport.com/methodology