510(k) · Cleared
ClearedTissue Containment System; 10, 14, 17, 25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 23, 2014 as substantially equivalent to K060051 (Applied Medical Resources Corp., 2006) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Dec 23, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910914 (1991). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK910914 Surgical Tissue PouchCook Urological, Inc. · 1991 · Recalled
- This deviceK142427 Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014
- Descendant · cites it directly · 1 of its ownK211043 Alexis Contained Extraction SystemApplied Medical Resources Corporation · 2022
- Descendant · cites it directly · 1 of its ownK211234 RedExAdvanced Surgical Concepts, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK150781 Tissue Removal PouchBoehringer Laboratories, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK232701 Guardenia (GAR-1)Advanced Surgical Concepts · 2023
- Descendant · 2 generations on · 0 of its ownK151990 Tissue Removal SystemBoehringer Laboratories, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K211043Alexis Contained Extraction SystemApplied Medical Resources Corporation · 2022 · cites it directly1descendant
- K211234RedExAdvanced Surgical Concepts, Ltd. · 2021 · cites it directly1descendant
- K150781Tissue Removal PouchBoehringer Laboratories, LLC · 2015 · cites it directly1descendant
- K232701Guardenia (GAR-1)Advanced Surgical Concepts · 2023 · 2 generations on0descendants
- K151990Tissue Removal SystemBoehringer Laboratories, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910914 | Surgical Tissue Pouch | Cook Urological, Inc. | 1991 | 1 |
| 0 (this device) | K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources | 2014 | — |
| +1 | K211043 | Alexis Contained Extraction System | Applied Medical Resources Corporation | 2022 | — |
| +1 | K211234 | RedEx | Advanced Surgical Concepts, Ltd. | 2021 | — |
| +1 | K150781 | Tissue Removal Pouch | Boehringer Laboratories, LLC | 2015 | — |
| +2 | K232701 | Guardenia (GAR-1) | Advanced Surgical Concepts | 2023 | — |
| +2 | K151990 | Tissue Removal System | Boehringer Laboratories, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K060051 | Specimen Retrieval SystemSummary page 4…Product Code: GCJ Regulation: 21 CFR 876.1500 Predicate Device: Applied Medical Specimen Retrieval System 510(k)#: K060051 Product Code: GCJ Regulation: 21 CFR 876.1500 Cook LapSac Tissue Entrapm… | 2006 |
| * | K910914 | Surgical Tissue PouchSummary page 4…Product Code: GCJ Regulation: 21 CFR 876.1500 Cook LapSac Tissue Entrapment Pouch 510(k)#: K910914 Product Code: KGY Regulation: 21 CFR 878.4100 Device Description: The Applied Medical Tissue… | 1991 |
What descends from it? (5)
3 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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
Contraindications:
The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Containment System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142427: Tissue Containment System; 10, 14, 17, 25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142427
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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