510(k) · Cleared
Recalled · Class I · 2016Laparoscopic Retractors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 22, 2010 as substantially equivalent to K933008 (Baxter Healthcare Corp, 1994) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1994. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jan 22, 2010
- Review
- 143 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933008 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK933008 Retractors and ScraperBaxter Healthcare Corp · 1994
- This deviceK092684 Laparoscopic RetractorsCardinal Health, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK112659 Surgical RetractorsSurgical Innovations Plc · 2012
- Descendant · cites it directly · 0 of its ownK100442 Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933008 | Retractors and Scraper | Baxter Healthcare Corp | 1994 | — |
| 0 (this device) | K092684 | Laparoscopic Retractors | Cardinal Health, Inc. | 2010 | — |
| +1 | K112659 | Surgical Retractors | Surgical Innovations Plc | 2012 | — |
| +1 | K100442 | Fastclamp Endoscopic Clamping System | Surgical Innovations Group Plc | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933008 | Retractors and ScraperSummary page 1…II Regulation Number: 21 CFR §876.1500 Procode: GCJ Predicate Devices: K933008, Laparoscopic Retractors and Scraper K9… | 1994 |
| * | K930667 | Reusable Laparoscopic InstrumentsSummary page 1…edicate Devices: K933008, Laparoscopic Retractors and Scraper K930667, Reusable Laparoscopic Instruments Description: The… | 1994 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2016 | Class I | Z-2212-2016 | Material/Component Contamination | BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K112659 (Surgical Innovations Plc, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092684: Laparoscopic Retractors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092684
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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