510(k) · Cleared
ClearedDisposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Surgical Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 1, 2015 as substantially equivalent to K103509 (Unimax Medical Systems, Inc., 2011) after a 57-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Apr 1, 2015
- Review
- 57 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963646 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK963646 Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy · 1997 · Recalled
- 2 generations backK041967 Genicon Suction Irrigation SystemGenicon · 2004
- 1 generation backK103509 Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011
- This deviceK150253 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation…Taiwan Surgical Corporation · 2015
- Descendant · cites it directly · 0 of its ownK243867 LAGIS Suction Irrigation SystemLagis Enterprise Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243867LAGIS Suction Irrigation SystemLagis Enterprise Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963646 | Stryker Strykeflow Suction Irrigator Gravity Flow | Stryker Endoscopy | 1997 | 2 |
| −2 | K041967 | Genicon Suction Irrigation System | Genicon | 2004 | — |
| −1 | K103509 | Unimax Suction Irrigation Set | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | Taiwan Surgical Corporation | 2015 | — |
| +1 | K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K103509 | Unimax Suction Irrigation SetSummary page 4…Irrigation accessories III. PREDICATE DEVICE Predicate device 1: UNIMAX MEDICAL SYSTEM INC., K103509 5-2… | 2011 |
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 |
|---|---|---|---|
| K243867 | LAGIS Suction Irrigation System | 2025 | 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 18 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K243867 (Lagis Enterprise Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103509.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Suction Irrigation is indicated for general purpose use as suction/irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150253: Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150253
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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