510(k) · Cleared
Recalled · Class II · 2013Specimen Retrieval System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 19, 2006 after a 13-day review. The FDA summary names no predicate by number. 15 later devices descend from it. It has been recalled once.
- Decided
- Jan 19, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 4 citing it directly.
- This deviceK060051 Specimen Retrieval SystemApplied Medical Resources Corp. · 2006
- Descendant · cites it directly · 7 of its ownK100959 Specimen Retrieval SystemApplied Medical Resources · 2010
- Descendant · cites it directly · 5 of its ownK142427 Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014
- Descendant · 2 generations on · 3 of its ownK103510 Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK172789 Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute · 2018
- Descendant · 2 generations on · 1 of its ownK211043 Alexis Contained Extraction SystemApplied Medical Resources Corporation · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K100959Specimen Retrieval SystemApplied Medical Resources · 2010 · cites it directly7descendants
- K142427Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014 · cites it directly5descendants
- K103510Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc. · 2011 · 2 generations on3descendants
- K172789Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute · 2018 · 2 generations on2descendants
- K211043Alexis Contained Extraction SystemApplied Medical Resources Corporation · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060051 | Specimen Retrieval System | Applied Medical Resources Corp. | 2006 | — |
| +1 | K100959 | Specimen Retrieval System | Applied Medical Resources | 2010 | — |
| +1 | K142427 | Tissue Containment System; 10, 14, 17, 25 | Applied Medical Resources | 2014 | — |
| +2 | K103510 | Unimax Specimen Retrieval System | Unimax Medical Systems, Inc. | 2011 | 1 |
| +2 | K172789 | Specimen Retrieval Bag | Beijing Hangtian Kadi Technology R&D Institute | 2018 | — |
| +2 | K211043 | Alexis Contained Extraction System | Applied Medical Resources Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (15)
See all 154 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2013 | Class II | Z-0183-2014 | Package design/selection | Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100959 (Applied Medical Resources, 2010) has gone furthest, with 7 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 Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060051: Specimen Retrieval System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060051
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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