510(k) · Cleared
ClearedGuardenia (GAR-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Surgical Concepts · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 29, 2023 as substantially equivalent to K211234 (Advanced Surgical Concepts, Ltd., 2021) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Sep 29, 2023
- Review
- 24 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K910914 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK910914 Surgical Tissue PouchCook Urological, Inc. · 1991 · Recalled
- 2 generations backK142427 Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014
- 1 generation backK211234 RedExAdvanced Surgical Concepts, Ltd. · 2021
- This deviceK232701 Guardenia (GAR-1)Advanced Surgical Concepts · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910914 | Surgical Tissue Pouch | Cook Urological, Inc. | 1991 | 1 |
| −2 | K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources | 2014 | — |
| −1 | K211234 | RedEx | Advanced Surgical Concepts, Ltd. | 2021 | — |
| 0 (this device) | K232701 | Guardenia (GAR-1) | Advanced Surgical Concepts | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K211234 | RedExSummary page 5…CFR 876.1500 Product Code GCJ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211234 RedEx GCJ K211043 Alexis CES GCJ Device Description Summary 21 CFR 807.92(a)(4) Device Description Summary The Advanced Surgical… | 2021 |
| * | K211043 | Alexis Contained Extraction SystemSummary page 5…ct Code GCJ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211234 RedEx GCJ K211043 Alexis CES GCJ Device Description Summary 21 CFR 807.92(a)(4) Device Description Summary The Advanced Surgical Concepts Ltd, Gua… | 2022 |
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 32 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 5 ancestors have 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. 2023, 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 Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
Guardeniais contraindicated for use with laparoscopic power morcellators.
Guardenia 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232701: Guardenia (GAR-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232701
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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