510(k) · Cleared

Cleared

Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112

K020307510(k) TraditionalCleared Apr 26, 200287-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

Hakko Shoji Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 26, 2002 as substantially equivalent to K010870 (Ethicon Endo-Surgery, Inc., 2001) after an 87-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.

Decided: Apr 26, 2002
Review: 87 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010870 (2001). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010870 Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112…Ethicon Endo-Surgery, Inc. · 2001
This deviceK020307 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 2 of 2 · See all

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
−1	K010870	Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70…	Ethicon Endo-Surgery, Inc.	2001	—
0 (this device)	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
2003	1	0
2007	1	0

FIG. 1 — Lineage of K020307, 2001–2007Source: 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
*	K010870	Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70… Summary page 1 …Device Trade Name: LAP DISC Hand Access Device Classification Name: Laparoscope, General & Plastic Surgery Predicate Devices: LAP DISC Hand Access Device, cleared under K010870 on 06/18/01 Device Description The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closu…	Ethicon Endo-Surgery, Inc.	2001	—

Also cleared against K010870: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
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?

Its one ancestor has no recall.
Of its descendants, K030824 (Hakko Medical Co., Ltd., 2003) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K010870.

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 LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon’s hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

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/K020307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020307: Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020307

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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