510(k) · Cleared
Recalled · Class II · 2017Ezee Retrieval
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genicon, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 29, 2016 as substantially equivalent to K922123 (United States Surgical, A Division of Tyco Healthc, 1993) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 29, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K061555 (2006). 4 ancestors in all, the oldest K922123 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK061555 Anchor Laparscopic Tissue Retieval SystemAnchor Products Co. · 2006 · Recalled
- 1 generation backK132375 Genistrong Single-Use Specimen Retrieval BagGenicon · 2014 · Recalled
- This deviceK162059 Ezee RetrievalGenicon, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK180579 Ezee RetrievalGenicon, Inc. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K180579Ezee RetrievalGenicon, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061555 | Anchor Laparscopic Tissue Retieval System | Anchor Products Co. | 2006 | 2 |
| −1 | K132375 | Genistrong Single-Use Specimen Retrieval Bag | Genicon | 2014 | 1 |
| 0 (this device) | K162059 | Ezee Retrieval | Genicon, Inc. | 2016 | — |
| +1 | K180579 | Ezee Retrieval | Genicon, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922123 | Auto Suture Disposable Endoscopic Specimen PouchSummary page 4…iance September 20, 2016 2. Device Name GENICON EZEE Retrieval 3. Substantially Equivalent Device Covidien Endo Catch Gold Specimen Pouch, 10mm, 173050G [K922123] Legally Marketed (unmodified) Device: GeniStrong Single Use Specimen Retrieval Bag, 10mm, 550-000-003 [K132375] 4. Des… | 1993 |
| * | K132375 | Genistrong Single-Use Specimen Retrieval BagSummary page 4…en Endo Catch Gold Specimen Pouch, 10mm, 173050G [K922123] Legally Marketed (unmodified) Device: GeniStrong Single Use Specimen Retrieval Bag, 10mm, 550-000-003 [K132375] 4. Description The GENICON EZEE Retrieval is comprised of a flexible plastic bag with a large, easily accessible openi… | 2014 |
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 |
|---|---|---|---|
| K180579 | Ezee Retrieval | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2017 | Class II | Z-1076-2018 | Device Design | Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K180579 (Genicon, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K922123.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 GENICON EZEE Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162059: Ezee Retrieval.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162059
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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