510(k) · Cleared

Cleared

Aesop System and Accessories

K960655510(k) TraditionalCleared May 3, 199678-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 May 3, 1996 as substantially equivalent to K931783 (Computer Motion, Inc., 1993) after a 78-day review. Its family tree reaches back 1 generation to 1993. 330 later devices descend from it.

Decided: May 3, 1996
Review: 78 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K931783 (1993). 330 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
This deviceK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
Descendant · cites it directly · 310 of its ownK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
Descendant · 2 generations on · 300 of its ownK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
Descendant · cites it directly · 254 of its ownK974771 Stryker SE5 Arthroscopy System with Hermes Voice ControlStryker Endoscopy · 1998
Descendant · 2 generations on · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
Descendant · 3 generations on · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003

Showing 5 of 330 descendants. See all descendants

Descendants cleared per year

1997high 36 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 330 · See all

K973700Hermes Operating Room Control CenterComputer Motion, Inc. · 1998 · cites it directly310descendants
K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998 · 2 generations on300descendants
K974771Stryker SE5 Arthroscopy System with Hermes Voice ControlStryker Endoscopy · 1998 · cites it directly254descendants
K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999 · 2 generations on253descendants
K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · 3 generations on238descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931783	Aesop (Automated Endoscopic System for Optimal Pos	Computer Motion, Inc.	1993	—
0 (this device)	K960655	Aesop System and Accessories	Computer Motion, Inc.	1996	—
+1	K973700	Hermes Operating Room Control Center	Computer Motion, Inc.	1998	—
+2	K980787	Hermes Operating Room Control Center with the Wom 20L Insufflator	Computer Motion, Inc.	1998	—
+1	K974771	Stryker SE5 Arthroscopy System with Hermes Voice Control	Stryker Endoscopy	1998	—
+2	K991696	Stryker Hermes-Ready Total Performance System	Stryker Instruments	1999	—
+3	K032117	Stryker Total Performance (TPS) System	Stryker Instruments	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	3	0
1999	5	0
2002	5	0
2003	9	0
2004	6	0
2005	3	0
2006	5	0
2007	6	0
2008	12	0
2009	6	0
2010	13	0
2011	5	0
2012	6	0
2013	12	0
2014	10	0
2015	13	0
2016	17	0
2017	8	0
2018	15	0
2019	9	0
2020	17	0
2021	14	0
2022	26	0
2023	19	0
2024	30	0
2025	36	0
2026	18	0

FIG. 1 — Lineage of K960655, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K931783	Aesop (Automated Endoscopic System for Optimal Pos Summary page 1 …m Common Name: Antomated Endoscopic System for Optimal Positioning Classification Name: Opersting Room Table and Accessories 3) Substantially equivalent to AESOP 510(k) K931783 4) The AESOP System is a robotic computer-driven system whose basic function is to hold and position a lsparoscope under the dir…	Computer Motion, Inc.	1993	—

Also cleared against K931783: 6 other devices →

What descends from it? (330)

See all 330

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

Number	Device	Applicant	Decided	Descendants
K973700	Hermes Operating Room Control Center	Computer Motion, Inc.	1998	310
K974771	Stryker SE5 Arthroscopy System with Hermes Voice Control	Stryker Endoscopy	1998	254
K963126	Aesop System and Accessories	Computer Motion, Inc.	1997	58
K972699	Aesop 3000 System and Accessories	Computer Motion, Inc.	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?

Its one ancestor has no recall.
Of its descendants, K973700 (Computer Motion, Inc., 1998) has gone furthest, with 310 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

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

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 lapsroscope. It is indicated for use in all forms of laparoscopic surgery. A few examples are cholecystecomy, laparoscopic hemis repair, and laparoscopic appendectomy.

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/K960655 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960655: Aesop System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960655

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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