510(k) · Cleared

Cleared

Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113

K010870510(k) TraditionalCleared Jun 18, 200187-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

Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 18, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Jun 18, 2001
Review: 87 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

3 later devices descend from it, 3 citing it directly.

This deviceK010870 Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112…Ethicon Endo-Surgery, Inc. · 2001
Descendant · cites it directly · 2 of its ownK020307 Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112Hakko Shoji Co., Ltd. · 2002
Descendant · cites it directly · 1 of its ownK030824 Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX…Hakko Medical Co., Ltd. · 2003
Descendant · cites it directly · 0 of its ownK070198 Endopath Dextrus Seal Cap Assembly with Accessories and Endopath…Ethicon Endo-Surgery, LLC · 2007

Most influential descendants

Showing 3 of 3 · See all

K020307Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112Hakko Shoji Co., Ltd. · 2002 · cites it directly2descendants
K030824Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112Hakko Medical Co., Ltd. · 2003 · cites it directly1descendant
K070198Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length…Ethicon Endo-Surgery, LLC · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010870	Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70…	Ethicon Endo-Surgery, Inc.	2001	—
+1	K020307	Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112	Hakko Shoji Co., Ltd.	2002	—
+1	K030824	Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112	Hakko Medical Co., Ltd.	2003	—
+1	K070198	Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus…	Ethicon Endo-Surgery, LLC	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2007	1	0

FIG. 1 — Lineage of K010870, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K020307	Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112	Hakko Shoji Co., Ltd.	2002	2
K030824	Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112	Hakko Medical Co., Ltd.	2003	1
K070198	Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length…	Ethicon Endo-Surgery, LLC	2007	0

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?

Of its descendants, K020307 (Hakko Shoji Co., Ltd., 2002) has gone furthest, with 2 descendants of its own.

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	—

https://510kreport.com/device/K010870 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010870: Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70, Model LD113.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010870

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026