# K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 11, 2000 after 539 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930667 (1994). 4 ancestors in all.
269 later devices descend from it; 21 cite it directly.
1 of 274 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931340: Grasp Forceps/Scissors/Needle Holder/Dissector, Baxter Healthcare Corp (1993) Summary page 1.
- K960400: Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts), Snowden-Pencer (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K975001: Intuitive Surgical™ Endoscopic Instrument Control System and selected instruments. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200 (2002), 260 descendants of its own
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000 (2002), 260 descendants of its own
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments (2004), 258 descendants of its own
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family (2002), 254 descendants of its own
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own

## Recalls of this device
- Oct 4, 2007 · Not classified · Z-0152-2008: Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation
- Oct 4, 2007 · Not classified · Z-0151-2008: Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. 
- May 3, 2007 · Not classified · Z-1244-2007: Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clari

## 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 s endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment. Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels. forceps/pick-ups, needle holders, clip appliers, 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/K990144
Methodology: https://510kreport.com/methodology