510(k) · Cleared
ClearedMTP Extraction Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mtp Medical Technical Promotion GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 9, 1999 after an 83-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jun 9, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK990912 MTP Extraction BagMtp Medical Technical Promotion GmbH · 1999
- Descendant · cites it directly · 2 of its ownK033842 Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval…Vernon-Carus Limited · 2004
- Descendant · 2 generations on · 1 of its ownK123728 Retrieval BagFlexbar Machine Corp. · 2013
- Descendant · cites it directly · 1 of its ownK013872 Rusch Memory BagRusch Intl. · 2002
- Descendant · 3 generations on · 0 of its ownK210248 Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK160801 Well Lead Extraction BagWell Lead Medical Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K033842Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of TissueVernon-Carus Limited · 2004 · cites it directly2descendants
- K123728Retrieval BagFlexbar Machine Corp. · 2013 · 2 generations on1descendant
- K013872Rusch Memory BagRusch Intl. · 2002 · cites it directly1descendant
- K210248Lab Bag with Fabric PouchAdvanced Medical Design Co., Ltd. · 2021 · 3 generations on0descendants
- K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990912 | MTP Extraction Bag | Mtp Medical Technical Promotion GmbH | 1999 | — |
| +1 | K033842 | Nubert, Albert and Hubert Impervious Bags for Endoscopic Retrieval of Tissue | Vernon-Carus Limited | 2004 | — |
| +2 | K123728 | Retrieval Bag | Flexbar Machine Corp. | 2013 | — |
| +1 | K013872 | Rusch Memory Bag | Rusch Intl. | 2002 | — |
| +3 | K210248 | Lab Bag with Fabric Pouch | Advanced Medical Design Co., Ltd. | 2021 | — |
| +2 | K160801 | Well Lead Extraction Bag | Well Lead Medical Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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?
The FDA summary names no predicate by number.
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, K033842 (Vernon-Carus Limited, 2004) has gone furthest, with 2 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 | — |
What is it indicated for?
The Extraction Bag for use in Laparoscopy is intended for use by qualified surgeons during laparoscopic procedures, including cholecystectomy, appendectomy, nephrectomy, lymphadenectomy, intestinal resection, oophorocystectomy and myomectomy.
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/K990912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990912: MTP Extraction Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990912
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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