510(k) · Cleared
ClearedRedEx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Surgical Concepts, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 17, 2021 as substantially equivalent to K142427 (Applied Medical Resources, 2014) after a 147-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Sep 17, 2021
- Review
- 147 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910914 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910914 Surgical Tissue PouchCook Urological, Inc. · 1991 · Recalled
- 1 generation backK142427 Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014
- This deviceK211234 RedExAdvanced Surgical Concepts, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK232701 Guardenia (GAR-1)Advanced Surgical Concepts · 2023
Most influential descendants
Showing 1 of 1 · See all- K232701Guardenia (GAR-1)Advanced Surgical Concepts · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910914 | Surgical Tissue Pouch | Cook Urological, Inc. | 1991 | 1 |
| −1 | K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources | 2014 | — |
| 0 (this device) | K211234 | RedEx | Advanced Surgical Concepts, Ltd. | 2021 | — |
| +1 | K232701 | Guardenia (GAR-1) | Advanced Surgical Concepts | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142427 | Tissue Containment System; 10, 14, 17, 25Summary page 4…GCJ Predicate Devices: Applied Medical Resources Corporation’s Applied Medical Tissue Containment System (K142427) a/k/a Alexis CES Device Description The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232701 | Guardenia (GAR-1) | 2023 | 0 |
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 30 years and passes through 3 companies; a new generation was cleared every 23.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K232701 (Advanced Surgical Concepts, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142427.
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 RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
RedEx is contraindicated for use with laparoscopic power and manual morcellators.
RedEx 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/K211234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211234: RedEx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211234
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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