510(k) · Cleared
ClearedEndopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors, HAP02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 13, 2007 as substantially equivalent to K030824 (Hakko Medical Co., Ltd., 2003) and 3 other predicates after a 142-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jun 13, 2007
- Review
- 142 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K010870 (2001). 5 ancestors in all, the oldest K954824 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK010870 Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112…Ethicon Endo-Surgery, Inc. · 2001
- 2 generations backK020307 Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112Hakko Shoji Co., Ltd. · 2002
- 1 generation backK030824 Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX…Hakko Medical Co., Ltd. · 2003
- This deviceK070198 Endopath Dextrus Seal Cap Assembly with Accessories and Endopath…Ethicon Endo-Surgery, LLC · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010870 | Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70… | Ethicon Endo-Surgery, Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K070198 | Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus… | Ethicon Endo-Surgery, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 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? (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 | Decided |
|---|---|---|---|
| * | K030824 | Lap Disc 120 X 120MM X2CM, Model LD111, Lap Disc 120 X 120MMX 7CM,Model LD112Summary page 1…c Surgery [21 CFR 878.4370 (KKX)] Predicate Devices LAP DISC Hand Access Device (Hakko Medical Division of Hakko Shoji, Co. Ltd.), cleared under K030824 on June 4, 2003, K020307 on April 26, 2002, and K0 10870 on June 18, 2001 AlexiSTM Wound… | 2003 |
| * | K020307 | Lap Disc 120 X 120MM X 2CM #LD111; Lap Disc 120 X 120MM X 7CM #LD112Summary page 1…0 (KKX)] Predicate Devices LAP DISC Hand Access Device (Hakko Medical Division of Hakko Shoji, Co. Ltd.), cleared under K030824 on June 4, 2003, K020307 on April 26, 2002, and K0 10870 on June 18, 2001 AlexiSTM Wound Retractors (Applied Medic… | 2002 |
| * | K010870 | Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70…Summary page 1…vice (Hakko Medical Division of Hakko Shoji, Co. Ltd.), cleared under K030824 on June 4, 2003, K020307 on April 26, 2002, and K0 10870 on June 18, 2001 AlexiSTM Wound Retractors (Applied Medical Resources Corp.), cleared un… | 2001 |
| * | K020435 | Wound Protector/RetractorSummary page 1…April 26, 2002, and K0 10870 on June 18, 2001 AlexiSTM Wound Retractors (Applied Medical Resources Corp.), cleared under K020435 on April 15, 2002 Device Description The device is asterile, single patient use abdominal access system comprised of two separa… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories. The ENDOPATH DEXTRUS Seal Cap…
Read the full statement (122 words)
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories, when used in conjunction with the ENDOPATH DEXTRUS Fixed-Length Access Retractor, is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during minimally invasive surgery.
The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070198: Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors, HAP02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070198
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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