# K040948: Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: May 5, 2004 after 23 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
Longest line of descent: 4 generations back to K930667 (1994). 14 ancestors in all.
229 later devices descend from it; 3 cite it directly.
1 of 244 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family, Intuitive Surgical, Inc. (2002) Summary page 1.
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000, Intuitive Surgical, Inc. (2002) Summary page 1.
- K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200, Intuitive Surgical, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), 211 descendants of its own
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182 (2006), 155 descendants of its own
- K061260: Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 (2006), 154 descendants of its own

## Indications for use
The Intuitive Surgical®Endoscopic Instrument Control System (hereinafter referred to as the"da Vinci® System") is intended to assist in the accurate control of Intuitive Surgical®Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions 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/K040948
Methodology: https://510kreport.com/methodology