510(k) · Cleared

Cleared

LTF-Y0009; Maj-YOO41; Xoev-3D1

K102379510(k) TraditionalCleared Jan 5, 2011135-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

Olympus Medical Systems Corporation · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jan 5, 2011 as substantially equivalent to K943304 (Olympus America, Inc., 1995) and 3 other predicates after a 135-day review. Its family tree reaches back 1 generation to 1995. 33 later devices descend from it.

Decided: Jan 5, 2011
Review: 135 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K943305 (1995). 4 ancestors in all. 33 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK943305 Olympus 3D Surgical Endoscopy SystemOlympus America, Inc. · 1995
This deviceK102379 LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation · 2011
Descendant · cites it directly · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
Descendant · cites it directly · 12 of its ownK113203 Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012
Descendant · 2 generations on · 9 of its ownK150377 Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony…Sony Electronics, Inc. · 2015
Descendant · 3 generations on · 7 of its ownK220069 4K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. · 2022 · Recalled
Descendant · 2 generations on · 7 of its ownK150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU…KARL STORZ Endoscopy-America, Inc. · 2015

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2012high 7 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 33 · See all

K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · cites it directly19descendants
K113203Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012 · cites it directly12descendants
K150377Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor…Sony Electronics, Inc. · 2015 · 2 generations on9descendants
K2200694K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. · 2022 · 3 generations on7descendants
K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc. · 2015 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943305	Olympus 3D Surgical Endoscopy System	Olympus America, Inc.	1995	—
0 (this device)	K102379	LTF-Y0009; Maj-YOO41; Xoev-3D1	Olympus Medical Systems Corporation	2011	—
+1	K123365	Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190	Olympus Medical Systems Corp.	2013	—
+1	K113203	Sony LMD-2451MT LCD Monitor	Sony Electronics, Inc.	2012	—
+2	K150377	Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD…	Sony Electronics, Inc.	2015	—
+3	K220069	4K UHD LCD Monitor OEV321UH	Olympus Medical Systems Corp.	2022	1
+2	K150525	SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link	KARL STORZ Endoscopy-America, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	2	0
2017	1	0
2018	1	0
2019	2	0
2020	4	0
2021	2	0
2022	2	0
2023	2	0
2024	4	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K102379, 1995–2026Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K943304	3D Surgical Endoscopy System for Urology Summary page 2 …wakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595 * 510(k) No. 3D Laparoscope - Urology (K943304) 3D Laparoscope - Ob/Gyn (K(943305) 30 Laparoscope - General Surger…	Olympus America, Inc.	1995	—
*	K943305	Olympus 3D Surgical Endoscopy System Summary page 2 …Establishment Registration No.: 9610595 * 510(k) No. 3D Laparoscope - Urology (K943304) 3D Laparoscope - Ob/Gyn (K(943305) 30 Laparoscope - General Surgery (K943307) LTF-VH (1(080948) 4 D…	Olympus America, Inc.	1995	—
*	K943307	3D Surgical Endoscopy System for General Surgery Summary page 2 …3D Laparoscope - Urology (K943304) 3D Laparoscope - Ob/Gyn (K(943305) 30 Laparoscope - General Surgery (K943307) LTF-VH (1(080948) 4 Device Description 3D Laparo-Thoraco Videoscope (LTF-Y0009) is a video end…	Olympus America, Inc.	1995	—
*	K080948	HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH Summary page 2 …3D Laparoscope - Ob/Gyn (K(943305) 30 Laparoscope - General Surgery (K943307) LTF-VH (1(080948) 4 Device Description 3D Laparo-Thoraco Videoscope (LTF-Y0009) is a video endoscope used for endoscopy and endoscopic surgery…	Olympus Medical Systems Corporation	2008	—

Also cleared against K943304: 1 other device →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K123365	Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190	Olympus Medical Systems Corp.	2013	19
K113203	Sony LMD-2451MT LCD Monitor	Sony Electronics, Inc.	2012	12

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?

None of the 4 ancestors has a recall.
Of its descendants, K123365 (Olympus Medical Systems Corp., 2013) has gone furthest, with 19 descendants of its own.
1 other device also cites its predicate K943304.

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. 2011, this device’s year, is highlighted.

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?

This instrument has been designed for use in conjunction with light source, video system centers, 3D video mixer, 3D monitor, documentation equipment, hand instruments, and other ancillary equipment for endoscopy and endoscopic surgery within the peritoneal and thoracic cavity. This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope and video system center for 3D video observation. This instrument has been designed to be…

Read the full statement (116 words)

This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope and video system center for 3D video observation.

This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope, light source, video system center and 3D video mixer for endoscopic diagnosis and video observation.

This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope, light source, video system center, 3D Video Mixer and 3D monitor for 3D video observation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102379 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102379: LTF-Y0009; Maj-YOO41; Xoev-3D1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102379

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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