510(k) · Cleared
ClearedNubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vernon-Carus Limited · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 4, 2004 as substantially equivalent to K990912 (Mtp Medical Technical Promotion GmbH, 1999) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 4, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923945 (1993). 6 ancestors in all, the oldest K922123 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923945 Pleatman Sac Specimen ContainerCabot Medical Corp. · 1993 · Recalled
- 2 generations backK012150 Patton Endo-BagPatton Medical Corp. · 2001
- 1 generation backK030422 Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003
- This deviceK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- Descendant · cites it directly · 1 of its ownK123728 Retrieval BagFlexbar Machine Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK210248 Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923945 | Pleatman Sac Specimen Container | Cabot Medical Corp. | 1993 | 1 |
| −2 | K012150 | Patton Endo-Bag | Patton Medical Corp. | 2001 | — |
| −1 | K030422 | Lina-Bag, Models LB-60, LB-100 | Lina Medical Cml Aps | 2003 | — |
| 0 (this device) | K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | Vernon-Carus Limited | 2004 | — |
| +1 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| +2 | K210248 | Lab Bag with Fabric Pouch | Advanced Medical Design Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K990912 | MTP Extraction BagSummary page 1…Laparoscopic, General and Plastic Surgery 21 CFR 876.1500 Predicate Devices: * Mtp Endobago Disposable Extraction Bag (K990912); * LiNA-Bag (K030422) Device Description: Single-use disposable device used as a receptacle for the collection and ex… | 1999 |
| * | K030422 | Lina-Bag, Models LB-60, LB-100Summary page 1…astic Surgery 21 CFR 876.1500 Predicate Devices: * Mtp Endobago Disposable Extraction Bag (K990912); * LiNA-Bag (K030422) Device Description: Single-use disposable device used as a receptacle for the collection and extraction of tissue during l… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123728 | Retrieval Bag | 2013 | 1 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K123728 (Flexbar Machine Corp., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K990912.
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 | — |
What is it indicated for?
The family of impervious bags for endoscopic retrieval of tissue are single-use disposable devices used as receptacles for the collection and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags fi)r the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval cf tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033842: Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033842
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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