510(k) · Cleared
ClearedHydro Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · GWG Endoscope, Neurological
Cleared on May 8, 2026 as substantially equivalent to K072410 (KARL STORZ Endoscopy-America, Inc., 2008) after a 168-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- May 8, 2026
- Review
- 168 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902683 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902683 Scopescrubber (TM)Healthtek Microsurgical, Inc. · 1990
- 2 generations backK982594 Endo-Scrub/Endo-Scrub 2Xomed, Inc. · 1998 · Recalled
- 1 generation backK072410 Ksea Clearvision II, Model 40334120KARL STORZ Endoscopy-America, Inc. · 2008
- This deviceK253679 Hydro Irrigation SystemStryker Instruments · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902683 | Scopescrubber (TM) | Healthtek Microsurgical, Inc. | 1990 | — |
| −2 | K982594 | Endo-Scrub/Endo-Scrub 2 | Xomed, Inc. | 1998 | 1 |
| −1 | K072410 | Ksea Clearvision II, Model 40334120 | KARL STORZ Endoscopy-America, Inc. | 2008 | — |
| 0 (this device) | K253679 | Hydro Irrigation System | Stryker Instruments | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 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 |
|---|---|---|---|
| * | K072410 | Ksea Clearvision II, Model 40334120Summary page 5…ass II Product Code: GWG 510(k) Review Panel: Neurology Predicate Device(s): Karl Storz Clearvision II Len Irrigation System K072410 (predicate) Medtronic Integrated Power Console (IPC) K081277 (reference1) NOTE 1: The reference device is i… | 2008 |
| † | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | 2008 |
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 36 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K072410.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
The Hydro Irrigation Console (console) and its accessories (also referred to as the Hydro Irrigation System) are intended for cleaning the distal lens of rigid endoscopes and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253679: Hydro Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253679
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026