510(k) · Cleared
ClearedOne-Handed Endopouch Specimen Retrieval Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 13, 1993 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 13, 1993
- Review
- 80 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK933104 One-Handed Endopouch Specimen Retrieval BagETHICON, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK012150 Patton Endo-BagPatton Medical Corp. · 2001
- Descendant · cites it directly · 3 of its ownK030422 Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003
- Descendant · 2 generations on · 2 of its ownK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- Descendant · 3 generations on · 1 of its ownK123728 Retrieval BagFlexbar Machine Corp. · 2013
- Descendant · 4 generations on · 0 of its ownK210248 Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K012150Patton Endo-BagPatton Medical Corp. · 2001 · cites it directly4descendants
- K030422Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003 · cites it directly3descendants
- K033842Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of TissueVernon-Carus Limited · 2004 · 2 generations on2descendants
- K123728Retrieval BagFlexbar Machine Corp. · 2013 · 3 generations on1descendant
- K210248Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933104 | One-Handed Endopouch Specimen Retrieval Bag | ETHICON, Inc. | 1993 | — |
| +1 | K012150 | Patton Endo-Bag | Patton Medical Corp. | 2001 | — |
| +1 | K030422 | Lina-Bag, Models LB-60, LB-100 | Lina Medical Cml Aps | 2003 | — |
| +2 | K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | Vernon-Carus Limited | 2004 | — |
| +3 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| +4 | K210248 | Lab Bag with Fabric Pouch | Advanced Medical Design Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012150 (Patton Medical Corp., 2001) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K933104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933104: One-Handed Endopouch 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/K933104
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026