Hydro Irrigation System
FDA 510(k) K253679 · Stryker Instruments
510(k) numberK253679
Submission
- Device name
- Hydro Irrigation System
- Applicant
- Stryker Instruments
Portage, MI, US - Received
- November 21, 2025
- Decision date
- May 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|---|
| K253602 | Precision S 4K SinuscopeGWG · Traditional | Stryker Endoscopy | 06/04/2026SE |
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| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | Integra LifeSciences Corporation | 04/09/2025SE |
| K233391 | cCeLL - In vivoGWG · Traditional | VPIX Medical, Inc. | 08/21/2024SE |
| K223615 | Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional | Clarus Medical, LLC | 11/21/2023SE |
| K232618 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 10/27/2023SE |
| K230125 | Neuroblade SystemGWG · Traditional | Clearmind Biomedical | 10/13/2023SE |
| K232159 | QEVO SystemGWG · Special | Carl Zeiss Meditec, AG | 09/21/2023SE |
| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…GWG · Traditional | Stryker | 08/06/2021SE |
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| K261544 | Hydro Irrigation SystemEOB · Traditional | 06/17/2026SE |
| K252282 | SurgiCount+ SystemPBZ · Traditional | 03/16/2026SE |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…OLO · Traditional | 09/25/2025SE |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | 09/09/2025SE |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional | 05/15/2025SE |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemGEI · Special | 04/15/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | 03/24/2025SE |
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| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | 03/11/2025SE |
| K242834 | System 9 Sterile Battery ContainerKCT · Traditional | 01/16/2025SE |
Questions and answers
When was Hydro Irrigation System cleared by the FDA?
Hydro Irrigation System (K253679) received a 510(k) decision of Substantially Equivalent on May 8, 2026, 168 days after the submission was received.
What is the product code of K253679?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.