510(k) · Cleared
Recalled · Class II · 2026Stryker Strykeflow Suction Irrigator Gravity Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 16, 1997 after a 216-day review. The FDA summary names its predicate without a number. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 16, 1997
- Review
- 216 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK963646 Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy · 1997
- Descendant · cites it directly · 9 of its ownK041967 Genicon Suction Irrigation SystemGenicon · 2004
- Descendant · 2 generations on · 8 of its ownK103509 Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK192643 Dannik Laparoscopic Suction Irrigation SystemDannik · 2019
- Descendant · 3 generations on · 2 of its ownK141592 Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK991323 Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K041967Genicon Suction Irrigation SystemGenicon · 2004 · cites it directly9descendants
- K103509Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011 · 2 generations on8descendants
- K192643Dannik Laparoscopic Suction Irrigation SystemDannik · 2019 · 3 generations on2descendants
- K141592Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014 · 3 generations on2descendants
- K991323Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963646 | Stryker Strykeflow Suction Irrigator Gravity Flow | Stryker Endoscopy | 1997 | — |
| +1 | K041967 | Genicon Suction Irrigation System | Genicon | 2004 | — |
| +2 | K103509 | Unimax Suction Irrigation Set | Unimax Medical Systems, Inc. | 2011 | — |
| +3 | K192643 | Dannik Laparoscopic Suction Irrigation System | Dannik | 2019 | — |
| +3 | K141592 | Unimicro Suction Irriation Tubing Set | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014 | — |
| +1 | K991323 | Smith & Nephew Subcutaneous Illuminator | Smith & Nephew, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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? (3)
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 |
|---|---|---|---|
| * | — | Nezhat-Dorsey device Named without a submission number | |
| * | — | Stryker Strykeflow Suction Irrigator Named without a submission number | |
| * | — | equivalent gravity flow and bulb/syringe devices Named without a submission number |
What descends from it? (13)
See all 132 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 |
|---|---|---|---|---|
| Jun 8, 2026 | Class II | Z-2865-2026 | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| Jun 8, 2026 | Class II | Z-2866-2026 | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041967 (Genicon, 2004) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery.
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/K963646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963646: Stryker Strykeflow Suction Irrigator Gravity Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963646
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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