510(k) · Cleared
ClearedIntuitive Surgical Monarch Laparoscopic Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 31, 1997 as substantially equivalent to K914190 (United States Surgical, A Division of Tyco Healthc, 1992) and 2 other predicates after a 227-day review. Its family tree reaches back 1 generation to 1992. 1 of the 267 devices in its family, counting itself, has a Class I recall. 263 later devices descend from it.
- Decided
- Jul 31, 1997
- Review
- 227 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914190 (1992). 3 ancestors in all. 263 later devices descend from it, 4 citing it directly. 1 of the 267 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK914190 Auto Suture (R) Endoscopic Fan RetractorUnited States Surgical, A Division of Tyco Healthc · 1992
- This deviceK965001 Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997
- Descendant · cites it directly · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
- Descendant · cites it directly · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- Descendant · cites it directly · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002
- Descendant · 2 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
Showing 5 of 263 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System4 generations on · 2023
Most influential descendants
Showing 5 of 263 · See all- K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · cites it directly260descendants
- K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · cites it directly260descendants
- K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · cites it directly258descendants
- K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · cites it directly254descendants
- K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 2 generations on251descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914190 | Auto Suture (R) Endoscopic Fan Retractor | United States Surgical, A Division of Tyco Healthc | 1992 | — |
| 0 (this device) | K965001 | Intuitive Surgical Monarch Laparoscopic Manipulator | Intuitive Surgical, Inc. | 1997 | — |
| +1 | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic… | Intuitive Surgical, Inc. | 2002 | — |
| +1 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| +1 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument Family | Intuitive Surgical, Inc. | 2002 | — |
| +2 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 18 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 17 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 1 |
| 2024 | 22 | 0 |
| 2025 | 31 | 0 |
| 2026 | 23 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914190 | Auto Suture (R) Endoscopic Fan RetractorSummary page 1…pt”) Instrument Positioning Accessory (IPA) And various atraumatic Class I Exempt surgical instruments including the US Surgical Auto Suture* Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169) and Medical Perspectives Corp. Kittner Dissector (K953059) === Page… | 1992 |
| * | K933169 | Inman Endoscopic Blunt DissectorSummary page 1…traumatic Class I Exempt surgical instruments including the US Surgical Auto Suture* Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169) and Medical Perspectives Corp. Kittner Dissector (K953059) souto =37 D738 From:iNTUITIVE SURGICAL 4155262066 T-… | 1994 |
| * | K953059 | Kittner DissectorSummary page 1…US Surgical Auto Suture* Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169) and Medical Perspectives Corp. Kittner Dissector (K953059) souto =37 D738 From:iNTUITIVE SURGICAL 4155262066 T-164 P.03/03 Job~265 310(k) SUMMARY (Continued) Device Des… | 1995 |
| * | — | Computer Motion AESOP Laparoscope Positioning and Control System Named without a submission number | |
| * | — | Andronic Devices Endex (originally “Adept”) Instrument Positioning Accessory (IPA) Named without a submission number |
What descends from it? (263)
See all 2634 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model… | 2002 | 260 |
| K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | 2002 | 260 |
| K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic… | 2004 | 258 |
| K013416 | Intuitive Surgical Endowrist Endoscopic Instrument Family | 2002 | 254 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965001: Intuitive Surgical Monarch Laparoscopic Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965001
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026