510(k) · Cleared
ClearedMerdoc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 5, 2003 as substantially equivalent to K991444 (Computer Motion, Inc., 1999) after a 317-day review. Its family tree reaches back 6 generations to 1993. 39 later devices descend from it.
- Decided
- Jun 5, 2003
- Review
- 317 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931783 (1993). 9 ancestors in all. 39 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 2 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 1 generation backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- This deviceK022393 Merdoc SystemStryker Endoscopy · 2003
- Descendant · cites it directly · 14 of its ownK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- Descendant · cites it directly · 13 of its ownK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- Descendant · 2 generations on · 12 of its ownK160332 Stryker SDC3 HD Information Management System with Wireless Device…Stryker Endoscopy · 2016
- Descendant · 2 generations on · 12 of its ownK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- Descendant · 3 generations on · 10 of its ownK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K121893Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012 · cites it directly14descendants
- K033135Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004 · cites it directly13descendants
- K160332Stryker SDC3 HD Information Management System with Wireless Device Control CapabilityStryker Endoscopy · 2016 · 2 generations on12descendants
- K053510IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · 2 generations on12descendants
- K181258ConnectedOR Hub with Device and Voice ControlStryker · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −2 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −1 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| 0 (this device) | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| +1 | K121893 | Stryker SDC3 HD Information Management System | Stryker Endoscopy | 2012 | — |
| +1 | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
| +2 | K160332 | Stryker SDC3 HD Information Management System with Wireless Device Control… | Stryker Endoscopy | 2016 | — |
| +2 | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | 2 |
| +3 | K181258 | ConnectedOR Hub with Device and Voice Control | Stryker | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Summary page 4…Sidne™ System is substantially equivalent in safety and efficacy as the currently marketed HERMES OR Control Center. The HERMES OR Cantro! Center was cleared under 510K# 991444 The Stryker Sidne™ Syslem is @ medical device that is designed to allow the surgeon to control the state, selection, and setting… | 1999 |
What descends from it? (39)
See all 394 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 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K121893 (Stryker Endoscopy, 2012) has gone furthest, with 14 descendants 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?
The Stryker Sidne™ System is indicated for use with compatible endoscopic and general surgery devices. The Stryker Sidne™ System can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope lendoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hemia repair, laparoscopic appendectomy, laparoscopic…
Read the full statement (142 words)
The Stryker Sidne™ System is indicated for use with compatible endoscopic and general surgery devices. The Stryker Sidne™ System can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope lendoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hemia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinat fusion, anterior cruciate ligament reconstruction, knee arthroscopy. shoulder arthroscopy, small joint arthroscopy, 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 Sidne™ 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/K022393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022393: Merdoc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022393
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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