510(k) · Cleared
ClearedEndoassist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armstrong Healthcare, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 26, 1997 as substantially equivalent to K931783 (Computer Motion, Inc., 1993) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Nov 26, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922626 (1992). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922626 Adept Instrument Positioning AccessoryAndronic Devices, Ltd. · 1992
- This deviceK973249 EndoassistArmstrong Healthcare, Ltd. · 1997
- Descendant · cites it directly · 2 of its ownK043284 EndoassistArmstrong Healthcare Limited · 2005
- Descendant · 2 generations on · 1 of its ownK090340 FreehandProsurgics Limited · 2009
- Descendant · 3 generations on · 0 of its ownK102179 Enview (TM)Carefusion 2200 · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922626 | Adept Instrument Positioning Accessory | Andronic Devices, Ltd. | 1992 | — |
| 0 (this device) | K973249 | Endoassist | Armstrong Healthcare, Ltd. | 1997 | — |
| +1 | K043284 | Endoassist | Armstrong Healthcare Limited | 2005 | — |
| +2 | K090340 | Freehand | Prosurgics Limited | 2009 | — |
| +3 | K102179 | Enview (TM) | Carefusion 2200 | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K931783 | Aesop (Automated Endoscopic System for Optimal PosSummary page 1…s being claimed 1. Automated Endoscopic System for Optimal Positioning (AESOP), manufactured and distributed by Computer Motion Inc. (California, USA). 510(k) reference K931783 2. Endex Endoscopy Positioning System, manufactured and distributed by Andronics Devices Ltd. (Canada). 510(k) reference K922626… | 1993 |
| * | K922626 | Adept Instrument Positioning AccessorySummary page 1…nc. (California, USA). 510(k) reference K931783 2. Endex Endoscopy Positioning System, manufactured and distributed by Andronics Devices Ltd. (Canada). 510(k) reference K922626 D. Device Description EndoAssist is a microprocessor-driven robotic arm which holds a rigid laparoscope for the surgeon during… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043284 | Endoassist | 2005 | 2 |
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?
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?
Endo Assist positions a Laparoscope and is indicated for use in laparoscopic thoracoscopic and pelvic procedures including laparoscopic cholecystectomy hernia repair Fundoplication Splenectomy appendectomy hemicolectomy
<2n(«bhe d:on)l
Lymph node dissection
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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/K973249 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973249: Endoassist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973249
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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