510(k) · Cleared
ClearedENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ximedica · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 1, 2024 as substantially equivalent to K232519 (Ximedica, 2024) after a 26-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Apr 1, 2024
- Review
- 26 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K061555 (2006). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK061555 Anchor Laparscopic Tissue Retieval SystemAnchor Products Co. · 2006 · Recalled
- 3 generations backK132375 Genistrong Single-Use Specimen Retrieval BagGenicon · 2014 · Recalled
- 2 generations backK180836 GenistrongGenicon, Inc. · 2018
- 1 generation backK232519 ENDOCOLLECT Specimen Retrieval BagXimedica · 2024
- This deviceK240635 ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen…Ximedica · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K061555 | Anchor Laparscopic Tissue Retieval System | Anchor Products Co. | 2006 | 2 |
| −3 | K132375 | Genistrong Single-Use Specimen Retrieval Bag | Genicon | 2014 | 1 |
| −2 | K180836 | Genistrong | Genicon, Inc. | 2018 | — |
| −1 | K232519 | ENDOCOLLECT Specimen Retrieval Bag | Ximedica | 2024 | — |
| 0 (this device) | K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag… | Ximedica | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K232519 | ENDOCOLLECT Specimen Retrieval BagSummary page 5…r 876.1500 Product Code(s) GCJ Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) ) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232519 ENDOCOLLECT Specimen Retrieval Bag GCJ Device Description Summary 21 CFR 807.92(a)(4) The ENDOCOLLECT Specimen Retrieval Bag (“E… | 2024 |
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 18 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 ENDOCOLLECT 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240635: ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240635
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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