# K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jun 26, 2002 after 86 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 18 (0 Class I)
- 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.
260 later devices descend from it; 15 cite it directly.
1 of 272 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)

## Most influential descendants
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments (2004), 258 descendants of its own
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument (2004), 235 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

## Recalls of this device
- May 21, 2014 · Class II · Z-1971-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1967-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1975-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1966-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1968-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1964-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1974-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1969-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1972-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1973-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1970-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- May 21, 2014 · Class II · Z-1965-2014: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Re
- Nov 15, 2013 · Class II · Z-0521-2014: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
- Nov 15, 2013 · Class II · Z-0520-2014: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
- 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
- Mar 9, 2005 · Not classified · Z-0723-05: Blades on the scissor may break and separate from the main unit as a result of corrosion damage.

## Indications for use
The Intuitive Surgical@Endoscopic Instrument Control System (hereinafter referred to as the “da VinctTMSystem”) is intended to assist in the accurate control of Intuitive Surgical’ endoscopicinstruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forcepdpick-ups, needle holders, endoscopic retractors, stabilizers, electrocauteryand accessories during laparoscopic surgical procedures such as cholecystectomy,Nissen fundoplication,radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures such as internal mammary artery mobilization. It is intended to be used by trained physicians in an operating room environment. Intuitive Surgical’ Endoscopic Instruments including scissors, scalpels, forcepslpick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocauteryand suturing.

Source page: https://510kreport.com/device/K021036
Methodology: https://510kreport.com/methodology