510(k) · Cleared
ClearedEndoassist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armstrong Healthcare Limited · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 25, 2005 as substantially equivalent to K973249 (Armstrong Healthcare, Ltd., 1997) and 2 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 91 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931783 (1993). 7 ancestors in all, the oldest K922626 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 4 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 3 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 2 generations backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- 1 generation backK023735 Lapman Laparoscope Manipulator System and Accessories, Model 900-001Medsys, S.A. · 2003
- This deviceK043284 EndoassistArmstrong Healthcare Limited · 2005
- Descendant · cites it directly · 1 of its ownK090340 FreehandProsurgics Limited · 2009
- Descendant · 2 generations on · 0 of its ownK102179 Enview (TM)Carefusion 2200 · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −4 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −3 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −2 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| −1 | K023735 | Lapman Laparoscope Manipulator System and Accessories, Model 900-001 | Medsys, S.A. | 2003 | — |
| 0 (this device) | K043284 | Endoassist | Armstrong Healthcare Limited | 2005 | — |
| +1 | K090340 | Freehand | Prosurgics Limited | 2009 | — |
| +2 | K102179 | Enview (TM) | Carefusion 2200 | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K973249 | EndoassistSummary page 1…r The classification name is rigid endoscope accessory The classification group code is GCJ per CFR Section 21 876.1500 Predicate Devices EndoAssist K973249, AESOP 3000 K972699, Lapman K023735 Description of Device EndoAssist is a head-controlled Endoscopic camera manipulato… | 1997 |
| * | K972699 | Aesop 3000 System and AccessoriesSummary page 1…ation name is rigid endoscope accessory The classification group code is GCJ per CFR Section 21 876.1500 Predicate Devices EndoAssist K973249, AESOP 3000 K972699, Lapman K023735 Description of Device EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended fo… | 1997 |
| * | K023735 | Lapman Laparoscope Manipulator System and Accessories, Model 900-001Summary page 1…gid endoscope accessory The classification group code is GCJ per CFR Section 21 876.1500 Predicate Devices EndoAssist K973249, AESOP 3000 K972699, Lapman K023735 Description of Device EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended for use in mi… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090340 | Freehand | 2009 | 1 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K090340 (Prosurgics Limited, 2009) has gone furthest, with 1 descendant of its own.
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?
EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use. A few examples of the more common endoscopic surgeries are laparoscopic* cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding gastric by pass…
Read the full statement (139 words)
EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.
A few examples of the more common endoscopic surgeries are laparoscopic*
cholecystectomy
hernia repair
fundoplication
splenectomy
appendectomy
hemicolectomy
sympathectomy
lymph node dissection
hysterectomy
gastric banding
gastric by pass
nephrectomy
radical prostatectomy
anterior spinal fusion, decompression fixation
wedge resection
lung biopsy
pleural biopsy,
internal mammary artery dissection for coronary artery bypass
coronary artery bypass grafting where endoscopic visualization is indicated
examination of the evacuated cardiac chamber during performance of valve replacement or repair.
The users of EndoAssist are general surgeons, bariatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons and urologists
* In this context "laparoscopic" is taken to embrace the use of a rigid endoscope in any part of the body
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043284: Endoassist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043284
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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