510(k) · Cleared
ClearedCabot Medical Surgiflex (R) Suction-Irrigation Prob
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cabot Medical Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 8, 1994 after a 372-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.
- Decided
- Jun 8, 1994
- Review
- 372 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 2 citing it directly.
- This deviceK932626 Cabot Medical Surgiflex (R) Suction-Irrigation ProbCabot Medical Corp. · 1994
- Descendant · cites it directly · 30 of its ownK992126 Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
- Descendant · 2 generations on · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
- Descendant · 3 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
- Descendant · 4 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
- Descendant · 5 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999 · cites it directly30descendants
- K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · 2 generations on23descendants
- K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 3 generations on16descendants
- K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 4 generations on8descendants
- K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932626 | Cabot Medical Surgiflex (R) Suction-Irrigation Prob | Cabot Medical Corp. | 1994 | — |
| +1 | K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation System | Circon Corp. | 1999 | — |
| +2 | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens… | New Wave Surgical Corporation | 2006 | 2 |
| +3 | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 | Minimally Invasive Devices, LLC | 2008 | — |
| +4 | K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2015 | — |
| +5 | K160172 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (34)
See all 342 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992126 (Circon Corp., 1999) has gone furthest, with 30 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 | — |
https://510kreport.com/device/K932626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932626: Cabot Medical Surgiflex (R) Suction-Irrigation Prob.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932626
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026