# K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jan 10, 2002 after 87 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930667 (1994). 11 ancestors in all.
254 later devices descend from it; 11 cite it directly.
1 of 266 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965001: Intuitive Surgical Monarch Laparoscopic Manipulator, Intuitive Surgical, Inc. (1997) Summary page 1.
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System, Intuitive Surgical, Inc. (2001) Summary page 1.
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000, Intuitive Surgical, Inc. (2001) Summary page 1.

## Most influential descendants
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 (2005), 231 descendants of its own
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000 (2005), 230 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

## Indications for use
Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

Source page: https://510kreport.com/device/K013416
Methodology: https://510kreport.com/methodology