# K011281: Intuitive Surgical Ultrasonic Shears

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 24, 2001 after 88 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- 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
No predicates in its family tree.
236 later devices descend from it; 4 cite it directly.
1 of 237 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument (2004), 235 descendants of its own
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 229 descendants of its own
- K043288: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 229 descendants of its own
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), 228 descendants of its own
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000 (2006), 224 descendants of its own

Source page: https://510kreport.com/device/K011281
Methodology: https://510kreport.com/methodology