510(k) · Cleared
ClearedEndolink True Movement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novare Surgical Systems, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 10, 2005 as substantially equivalent to K984240 (Ethicon Endo-Surgery, Inc., 1999) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Mar 10, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910831 (1991). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 1 generation backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- This deviceK043541 Endolink True Movement SystemNovare Surgical Systems, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK071488 Realhand High Dexterity (HD) InstrumentsNovare Surgical Systems, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK072715 Realhand High Dexterity InstrumentsNovare Surgical Systems, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK212736 Canady Flex RoboWristUs Medical Innovations, LLC · 2022
- Descendant · cites it directly · 0 of its ownK072811 Marionette SA, Model 001 001 & 001 002Kinetic Surgical, LLC · 2008
Most influential descendants
Showing 4 of 4 · See all- K071488Realhand High Dexterity (HD) InstrumentsNovare Surgical Systems, Inc. · 2007 · cites it directly2descendants
- K072715Realhand High Dexterity InstrumentsNovare Surgical Systems, Inc. · 2007 · cites it directly1descendant
- K212736Canady Flex RoboWristUs Medical Innovations, LLC · 2022 · 2 generations on0descendants
- K072811Marionette SA, Model 001 001 & 001 002Kinetic Surgical, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −1 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| 0 (this device) | K043541 | Endolink True Movement System | Novare Surgical Systems, Inc. | 2005 | — |
| +1 | K071488 | Realhand High Dexterity (HD) Instruments | Novare Surgical Systems, Inc. | 2007 | — |
| +1 | K072715 | Realhand High Dexterity Instruments | Novare Surgical Systems, Inc. | 2007 | — |
| +2 | K212736 | Canady Flex RoboWrist | Us Medical Innovations, LLC | 2022 | — |
| +1 | K072811 | Marionette SA, Model 001 001 & 001 002 | Kinetic Surgical, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2022 | 1 | 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.
Planning a device in GCJ? 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? (2)
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 |
|---|---|---|---|
| * | K984240 | Endopath Endoscopic InstrumentsSummary page 1…T is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization. Predicate Devices K984240 Endopath Endoscopic Instruments Ethicon Endo-Surgical, Inc. K972510 Pivotal Grasp… | 1999 |
| * | K972510 | Pivotal ScissorSummary page 1…and endoscopic visualization. Predicate Devices K984240 Endopath Endoscopic Instruments Ethicon Endo-Surgical, Inc. K972510 Pivotal Grasper / Dissector / Scissors Imagyn Surgical Device Description The Endolink… | 1997 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K071488 (Novare Surgical Systems, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K984240.
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 EndolinkTM True Movement SystemTM is intended for grasping, mobilization, dissection and transection of tissue under direct and endoscopic visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043541: Endolink True Movement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043541
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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