510(k) Report

510(k) · Cleared

Cleared

Hermes Operating Room Control Center

K973700510(k) TraditionalCleared Feb 24, 1998151-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Computer Motion, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Feb 24, 1998 as substantially equivalent to K931783 (Computer Motion, Inc., 1993) and 2 other predicates after a 151-day review. Its family tree reaches back 2 generations to 1993. 310 later devices descend from it.

Decided
Feb 24, 1998
Review
151 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K931783 (1993). 3 ancestors in all. 310 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2003: 8 descendants cleared2002: 5 descendants cleared1998: 1 descendant cleared1999: 5 descendants cleared2006: 5 descendants cleared2005: 2 descendants cleared2004: 6 descendants cleared2008: 11 descendants cleared2016: 17 descendants cleared2010: 12 descendants cleared2007: 5 descendants cleared2013: 10 descendants cleared2009: 5 descendants cleared2015: 12 descendants cleared2022: 26 descendants cleared2011: 5 descendants cleared2017: 8 descendants cleared2025: 34 descendants cleared2021: 14 descendants cleared2024: 29 descendants cleared2023: 18 descendants cleared2012: 6 descendants cleared2014: 10 descendants cleared2018: 14 descendants cleared2020: 16 descendants cleared2019: 9 descendants cleared2026: 17 descendants clearedK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 12 descendants3 generations forward: 13 descendants4 generations forward: 22 descendants5 generations forward: 30 descendants6 generations forward: 42 descendants7 generations forward: 62 descendants8 generations forward: 57 descendants9 generations forward: 35 descendants10 generations forward: 15 descendants11 generations forward: 9 descendants12 generations forward: 3 descendants13 generations forward: 1 descendant K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 19930+5+10
  1. Root · 2 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 1 generation backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. This deviceK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. Descendant · cites it directly · 300 of its ownK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. Descendant · cites it directly · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
  6. Descendant · 2 generations on · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
  7. Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
  8. Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006

Showing 5 of 310 descendants. See all descendants

Descendants cleared per year

1998: 11999: 52002: 52003: 82004: 62005: 22006: 52007: 52008: 112009: 52010: 122011: 52012: 62013: 102014: 102015: 122016: 172017: 82018: 142019: 92020: 162021: 142022: 262023: 182024: 292025: 342026: 17
1998high 34 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 310 · See all
  • K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998 · cites it directly300descendants
  • K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999 · cites it directly253descendants
  • K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · 2 generations on238descendants
  • K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−1K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
0 (this device)K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
+1K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
+1K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999—
+2K032117Stryker Total Performance (TPS) SystemStryker Instruments2003—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004—
+3K060033Profile Multi-Platform SystemSciton, Inc2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199950
200250
200380
200460
200520
200650
200750
2008110
200950
2010120
201150
201260
2013100
2014100
2015120
2016170
201780
2018140
201990
2020160
2021140
2022260
2023180
2024290
2025340
2026170
FIG. 1 — Lineage of K973700, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K931783Aesop (Automated Endoscopic System for Optimal Pos
Summary page 1
…ing Room Control Center and Accessories Common Name is HERMES Classification Name: Laparoscope, General & Plastic Surgery 3) Substantially equivalent to AESOP 510(k)’s K931783 and K960655; Model 882 Camera: K820624; Quantum 5000 Light Source: K961971. 4) The HERMES Operating Room Control Center is a co…
Computer Motion, Inc.1993—
*K960655Aesop System and Accessories
Summary page 1
…trol Center and Accessories Common Name is HERMES Classification Name: Laparoscope, General & Plastic Surgery 3) Substantially equivalent to AESOP 510(k)’s K931783 and K960655; Model 882 Camera: K820624; Quantum 5000 Light Source: K961971. 4) The HERMES Operating Room Control Center is a computer-drive…
Computer Motion, Inc.1996—
Kept off the family treeK820624FDA’s K820624 is Syn-Optics #5200
Our OCR of the scanned summary read K820624, FDA’s number for Syn-Optics #5200 (Syn-Optics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Model 882 Camera”. Kept off the family tree.
Summary page 1
…Common Name is HERMES Classification Name: Laparoscope, General & Plastic Surgery 3) Substantially equivalent to AESOP 510(k)’s K931783 and K960655; Model 882 Camera: K820624; Quantum 5000 Light Source: K961971. 4) The HERMES Operating Room Control Center is a computer-driven system whose basic FEB 24…
Syn-Optics1982—
*K961971Q-5000
Summary page 1
…n Name: Laparoscope, General & Plastic Surgery 3) Substantially equivalent to AESOP 510(k)’s K931783 and K960655; Model 882 Camera: K820624; Quantum 5000 Light Source: K961971. 4) The HERMES Operating Room Control Center is a computer-driven system whose basic FEB 24 1998 function is offer the additio…
Stryker Endoscopy1996—

Also cleared against K931783: 6 other devices →

What descends from it? (310)

See all 310

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998300
K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999253
K023095Hermes Operating Room Control CenterComputer Motion, Inc.20029
K024294Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20038
K030240Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20037
K031956Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030
K031720Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030
K031382Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030
K022897Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20020

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 5 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K980787 (Computer Motion, Inc., 1998) has gone furthest, with 300 descendants of its own.
  • 6 other devices also cite its predicate K931783.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the -more common endoscopic surgeries are laparoscopic chelecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically…

Read the full statement (130 words)

The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the -more common endoscopic surgeries are laparoscopic chelecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal: fusion, decompression fixatiof, wedge resection, lung biopsy, pleural biopsy, dorsal sgmpad\ectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visgalization is indicated and examiniation of the evacuated cardiac chamber during performance ©of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac Surgeons, thoracic surgeons, plastic surgeons, orthopedic sfirgeons, 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.

Cite this page

510(k) Report. “K973700: Hermes Operating Room Control Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973700

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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