510(k) · Cleared
ClearedEquipment Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 7, 2017 as substantially equivalent to K141593 (Unimicro Medical Systems (Shenzhen) Co., Ltd., 2014) after a 101-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Dec 7, 2017
- Review
- 101 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K060051 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK060051 Specimen Retrieval SystemApplied Medical Resources Corp. · 2006 · Recalled
- 3 generations backK100959 Specimen Retrieval SystemApplied Medical Resources · 2010
- 2 generations backK103510 Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc. · 2011 · Recalled
- 1 generation backK141593 Unimicro Disposable Retrieval Endo-PouchUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014
- This deviceK172578 Equipment PouchWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K060051 | Specimen Retrieval System | Applied Medical Resources Corp. | 2006 | 1 |
| −3 | K100959 | Specimen Retrieval System | Applied Medical Resources | 2010 | — |
| −2 | K103510 | Unimax Specimen Retrieval System | Unimax Medical Systems, Inc. | 2011 | 1 |
| −1 | K141593 | Unimicro Disposable Retrieval Endo-Pouch | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014 | — |
| 0 (this device) | K172578 | Equipment Pouch | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017 | — |
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 |
|---|---|---|---|
| * | K141593 | Unimicro Disposable Retrieval Endo-PouchSummary page 5…Unimicro Medical Systems (ShenZhen) Co., Ltd. Classification and Code Class II, GCJ Classification regulation 21 CFR 876.1500 510(k) number K141593 5. Intended Use and Indications for Use The Equipment Pouch is intended for use as a receptacle for the collection and extract… | 2014 |
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 11 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 4 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. 2017, 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 Equipment Pouch is intended for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
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/K172578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172578: Equipment Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172578
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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