510(k) · Cleared
Recalled · 2010Pleatman Sac Specimen Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cabot Medical Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 5, 1993 after a 185-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 5, 1993
- Review
- 185 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK923945 Pleatman Sac Specimen ContainerCabot Medical Corp. · 1993
- Descendant · cites it directly · 4 of its ownK012150 Patton Endo-BagPatton Medical Corp. · 2001
- Descendant · 2 generations on · 3 of its ownK030422 Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003
- Descendant · 3 generations on · 2 of its ownK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- Descendant · 4 generations on · 1 of its ownK123728 Retrieval BagFlexbar Machine Corp. · 2013
- Descendant · 5 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 · 2 generations on3descendants
- K033842Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of TissueVernon-Carus Limited · 2004 · 3 generations on2descendants
- K123728Retrieval BagFlexbar Machine Corp. · 2013 · 4 generations on1descendant
- K210248Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923945 | Pleatman Sac Specimen Container | Cabot Medical Corp. | 1993 | — |
| +1 | K012150 | Patton Endo-Bag | Patton Medical Corp. | 2001 | — |
| +2 | K030422 | Lina-Bag, Models LB-60, LB-100 | Lina Medical Cml Aps | 2003 | — |
| +3 | K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | Vernon-Carus Limited | 2004 | — |
| +4 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| +5 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012150 | Patton Endo-Bag | 2001 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2010 | Not classified | Z-2436-2010 | Packaging process control | Gyrus Medical, Inc. has issued a Urgent Medical Device Recall for the Gyrus ACMI product 004942-903 - Pleatman Sac Tissue Removal System, sold as lot 186540FC with an expiration date of 06/2015. As a result of a manufacturing error in the… |
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/K923945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923945: Pleatman Sac Specimen Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923945
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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