# K965001: Intuitive Surgical Monarch Laparoscopic Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 31, 1997 after 227 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 1 generation back to K914190 (1992). 3 ancestors in all.
263 later devices descend from it; 4 cite it directly.
1 of 267 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914190: Auto Suture (R) Endoscopic Fan Retractor, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.
- K933169: Inman Endoscopic Blunt Dissector, Inman Medical Corp. (1994) Summary page 1.
- K953059: Kittner Dissector, Medical Perspectives Corp. (1995) Summary page 1.
- (no number) Computer Motion AESOP Laparoscope Positioning and Control System: named in the summary without a submission number
- (no number) Andronic Devices Endex (originally “Adept”) Instrument Positioning Accessory (IPA): named in the summary without a submission number

## 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

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.

Source page: https://510kreport.com/device/K965001
Methodology: https://510kreport.com/methodology