510(k) · Cleared
ClearedLap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hakko Medical Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 4, 2003 as substantially equivalent to K010870 (Ethicon Endo-Surgery, Inc., 2001) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jun 4, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010870 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010870 Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112…Ethicon Endo-Surgery, Inc. · 2001
- 1 generation backK020307 Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112Hakko Shoji Co., Ltd. · 2002
- This deviceK030824 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2007 | 1 | 0 |
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
What was it cleared against? (2)
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070198 | Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length… | 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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K070198 (Ethicon Endo-Surgery, LLC, 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K010870.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 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, gynecologic and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030824: Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030824
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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