510(k) · Cleared
ClearedAesop System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computer Motion, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 7, 1997 as substantially equivalent to K931783 (Computer Motion, Inc., 1993) and 1 other predicate after a 238-day review. Its family tree reaches back 2 generations to 1993. 58 later devices descend from it.
- Decided
- Apr 7, 1997
- Review
- 238 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931783 (1993). 58 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 1 generation backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- This deviceK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- Descendant · cites it directly · 57 of its ownK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- Descendant · 2 generations on · 40 of its ownK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- Descendant · 3 generations on · 39 of its ownK022393 Merdoc SystemStryker Endoscopy · 2003
- Descendant · 4 generations on · 14 of its ownK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- Descendant · 4 generations on · 13 of its ownK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K972699Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997 · cites it directly57descendants
- K991444Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Computer Motion, Inc. · 1999 · 2 generations on40descendants
- K022393Merdoc SystemStryker Endoscopy · 2003 · 3 generations on39descendants
- K121893Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012 · 4 generations on14descendants
- K033135Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −1 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| 0 (this device) | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| +1 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| +2 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| +3 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| +4 | K121893 | Stryker SDC3 HD Information Management System | Stryker Endoscopy | 2012 | — |
| +4 | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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…mmon Name: Automated Endoscopic System for Optimal Positioning Classification Name: Laparoscope, General & Plastic Surgery 3) Substantially equivalent to AESOP 510(k)’s K931783 and K960655. 4) The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope/… | 1993 |
| * | K960655 | Aesop System and AccessoriesSummary page 1…utomated Endoscopic System for Optimal Positioning Classification Name: Laparoscope, General & Plastic Surgery 3) Substantially equivalent to AESOP 510(k)’s K931783 and K960655. 4) The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope/endoscope un… | 1996 |
What descends from it? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972699 | Aesop 3000 System and Accessories | 1997 | 57 |
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 4 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K972699 (Computer Motion, Inc., 1997) has gone furthest, with 57 descendants of its own.
- 6 other devices also cite its predicate K931783.
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 intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope. The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy…
Read the full statement (144 words)
The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope. The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the AESOP System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
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/K963126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963126: Aesop System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963126
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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