510(k) · Cleared
ClearedLapman Laparoscope Manipulator System and Accessories, Model 900-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsys, S.A. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 7, 2003 as substantially equivalent to K972699 (Computer Motion, Inc., 1997) after a 273-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Aug 7, 2003
- Review
- 273 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931783 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 3 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 2 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 1 generation backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- This deviceK023735 Lapman Laparoscope Manipulator System and Accessories, Model 900-001Medsys, S.A. · 2003
- 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 |
|---|---|---|---|---|---|
| −4 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −3 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −2 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −1 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| 0 (this device) | K023735 | Lapman Laparoscope Manipulator System and Accessories, Model 900-001 | Medsys, S.A. | 2003 | — |
| +1 | K043284 | Endoassist | Armstrong Healthcare Limited | 2005 | — |
| +2 | K090340 | Freehand | Prosurgics Limited | 2009 | — |
| +3 | K102179 | Enview (TM) | Carefusion 2200 | 2010 | — |
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? (1)
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 |
|---|---|---|---|
| * | K972699 | Aesop 3000 System and AccessoriesSummary page 1…Device: LapMan Laparoscope Manipulator. Classification: General and Plastic Surgery Class I I 21 CFR PART 876.1500 Predicate Device: AESOP 3000 System and accessories. K972699 THE AESOP 3000 is a robotic computer-driven system whose basic function is to hold and position a rigid laparoscope/endoscope und… | 1997 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K043284 (Armstrong Healthcare Limited, 2005) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K972699.
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 LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other surgical procedure or purpose.
The LapMan should only be used by qualified medical personnel, such as trained surgeons, gynecologists, urologists, and similarly-trained medical personnel trained in the use of laparoscopic/endoscopic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023735: Lapman Laparoscope Manipulator System and Accessories, Model 900-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023735
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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