510(k) · Cleared
ClearedLaparoGuard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mariner Endosurgery, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 13, 2018 as substantially equivalent to K121893 (Stryker Endoscopy, 2012) after a 98-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Dec 13, 2018
- Review
- 98 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931783 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 6 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 5 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 4 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 3 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 2 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 1 generation backK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- This deviceK182434 LaparoGuardMariner Endosurgery, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −7 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −6 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −5 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −4 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −3 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −2 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −1 | K121893 | Stryker SDC3 HD Information Management System | Stryker Endoscopy | 2012 | — |
| 0 (this device) | K182434 | LaparoGuard | Mariner Endosurgery, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K121893 | Stryker SDC3 HD Information Management SystemSummary page 4…and Product Code Endoscope and accessories, 21 CFR 876.1500, Class II, GCJ Predicate Devices Stryker Endoscopy’s SDC3 HD Information Management System (K121893) Indications for Use LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be us… | 2012 |
| † | K101979 | Explorer Liver (Passive Tracking) | 2011 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K121893.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be used in general laparoscopy wherever a laparoscope is indicated for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182434: LaparoGuard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182434
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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