510(k) · Cleared
Recalled · Class II · 2015Genistrong Single-Use Specimen Retrieval Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genicon · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 12, 2014 as substantially equivalent to K061555 (Anchor Products Co., 2006) and 1 other predicate after a 317-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 12, 2014
- Review
- 317 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K061555 (2006). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK061555 Anchor Laparscopic Tissue Retieval SystemAnchor Products Co. · 2006 · Recalled
- This deviceK132375 Genistrong Single-Use Specimen Retrieval BagGenicon · 2014
- Descendant · cites it directly · 2 of its ownK180836 GenistrongGenicon, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK232519 ENDOCOLLECT Specimen Retrieval BagXimedica · 2024
- Descendant · cites it directly · 1 of its ownK162059 Ezee RetrievalGenicon, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK240635 ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen…Ximedica · 2024
- Descendant · 2 generations on · 0 of its ownK180579 Ezee RetrievalGenicon, Inc. · 2018 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180836GenistrongGenicon, Inc. · 2018 · cites it directly2descendants
- K232519ENDOCOLLECT Specimen Retrieval BagXimedica · 2024 · 2 generations on1descendant
- K162059Ezee RetrievalGenicon, Inc. · 2016 · cites it directly1descendant
- K240635ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm…Ximedica · 2024 · 3 generations on0descendants
- K180579Ezee RetrievalGenicon, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061555 | Anchor Laparscopic Tissue Retieval System | Anchor Products Co. | 2006 | 2 |
| 0 (this device) | K132375 | Genistrong Single-Use Specimen Retrieval Bag | Genicon | 2014 | — |
| +1 | K180836 | Genistrong | Genicon, Inc. | 2018 | — |
| +2 | K232519 | ENDOCOLLECT Specimen Retrieval Bag | Ximedica | 2024 | — |
| +1 | K162059 | Ezee Retrieval | Genicon, Inc. | 2016 | 1 |
| +3 | K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag… | Ximedica | 2024 | — |
| +2 | K180579 | Ezee Retrieval | Genicon, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K061555 | Anchor Laparscopic Tissue Retieval SystemSummary page 1…ngle-Use Specimen Retrieval Bag and Introducer Classification: 21 CFR 876.1500 GCJ 3. Substantially Equivalent Device Anchor Tissue Retrieval Bag 100, 10mm introducer, K<061555, K<091930 4. Description The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easi… | 2006 |
| * | K091930 | Anchor Laparoscopic Tissue Retrieval System, Model TRS100SBSummary page 1…pecimen Retrieval Bag and Introducer Classification: 21 CFR 876.1500 GCJ 3. Substantially Equivalent Device Anchor Tissue Retrieval Bag 100, 10mm introducer, K<061555, K<091930 4. Description The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessi… | 2009 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2015 | Class II | Z-1642-2015 | Device Design | The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. |
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, K180836 (Genicon, Inc., 2018) has gone furthest, with 2 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. 2014, 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 Single-Use Specimen Retrieval Bag 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/K132375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132375: Genistrong Single-Use Specimen Retrieval Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132375
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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