510(k) · Cleared
ClearedLab Bag with Fabric Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Design Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 30, 2021 as substantially equivalent to K123728 (Flexbar Machine Corp., 2013) after a 182-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jul 30, 2021
- Review
- 182 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K923945 (1993). 8 ancestors in all, the oldest K922123 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK923945 Pleatman Sac Specimen ContainerCabot Medical Corp. · 1993 · Recalled
- 4 generations backK012150 Patton Endo-BagPatton Medical Corp. · 2001
- 3 generations backK030422 Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003
- 2 generations backK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- 1 generation backK123728 Retrieval BagFlexbar Machine Corp. · 2013
- This deviceK210248 Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923945 | Pleatman Sac Specimen Container | Cabot Medical Corp. | 1993 | 1 |
| −4 | K012150 | Patton Endo-Bag | Patton Medical Corp. | 2001 | — |
| −3 | 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 | — |
| −1 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K123728 | Retrieval BagSummary page 4…GCJ III. PREDICATE DEVICE Trade/Device Name Laparoscopic Tissue Retrieval Bag, Model 24003-MF 510(k) Number K123728 Product Code GCJ Submitter FLEXBAR MACHINE CORP. IV. DEVICE DESCRIPTION… | 2013 |
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 28 years and passes through 6 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 8 ancestors has 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. 2021, 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 Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of the tissue, organ or specimen during surgery.
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/K210248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210248: Lab Bag with Fabric Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210248
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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