Hydro Irrigation System
Device Facts
| Record ID | K253679 |
|---|---|
| Device Name | Hydro Irrigation System |
| Applicant | Stryker Instruments |
| Product Code | GWG · Neurology |
| Decision Date | May 8, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1480 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
System comprises irrigation console, disposable cassette, and foot switch; used in OR during endonasal neurosurgery. Foot switch signals console to drive peristaltic pump, delivering irrigation fluid from bag through tubing/sheath to endoscope distal lens. Provides 'Clean' (brief stream) and 'Flush' (continuous stream) modes. Optional RISE functionality enables ethernet integration with compatible Stryker devices for remote power/setting control. Surgeon operates system to maintain visualization without removing scope from surgical site; improves workflow efficiency and reduces OR clutter. Device uses 4-channel RFID for wireless communication.
Clinical Evidence
No clinical or animal data provided. Substantial equivalence supported by bench testing, including packaging/shelf-life (ISO 11607, ASTM F2096, F1886, F88, D4169, F1980), biocompatibility (ISO 10993 series, ASTM F756, F2901), sterilization/disinfection (AAMI TIR12, ST98, ISO 17664, 11135, 11737, ST72), software (IEC 62304), cybersecurity, and electrical/mechanical/thermal safety (IEC 60601 series, FCC Part 15).
Technological Characteristics
Microprocessor-controlled peristaltic pump; irrigation and reverse flow. Components: console, disposable cassette, foot switch. Connectivity: Ethernet (RISE), 4-channel RFID. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-4-2. Sterilization: ISO 11135. Biocompatibility: ISO 10993-1.
Indications for Use
Indicated for cleaning the distal lens of rigid endoscopes and maintaining clear visualization during endoscopic neurosurgical procedures using an endonasal approach.
Regulatory Classification
Identification
A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.
Predicate Devices
- Karl Storz Clearvision II Len Irrigation System (K072410)
Reference Devices
- Medtronic Integrated Power Console (IPC) (K081277)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 8, 2026
Stryker Instruments
Divya Sekar
Senior Principal, Regulatory Affairs Specialist
1941 Stryker Way
Kalamazoo, Michigan 49002
Re: K253679
Trade/Device Name: Hydro Irrigation System
Regulation Number: 21 CFR 882.1480
Regulation Name: Neurological Endoscope
Regulatory Class: Class II
Product Code: GWG
Dated: May 8, 2026
Received: May 8, 2026
Dear Divya Sekar:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253679 - Divya Sekar
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K253679 - Divya Sekar
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Sincerely,
JULIA E. SLOCOMB -S
Digitally signed by JULIA E. SLOCOMB-S
Date: 2026.05.08 13:40:08 -04'00'
for Jaime Raben, Ph.D.
Director
DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253679 | ? |
| Please provide the device trade name(s). | | ? |
| Hydro Irrigation System | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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K253679
# 510(k) Summary - K253679
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).
Submitter:
| Applicant | Stryker Instruments 1941 Stryker Way Portage, MI 49002, USA |
| --- | --- |
| Contact Person | Divya Sekar Senior Principal, Regulatory Affairs Specialist Email: divya.sekar@stryker.com Phone: 408-754-2473 |
| Date Prepared | May 2, 2026 |
Subject Device:
| Name of Device: | Hydro Irrigation System |
| --- | --- |
| Common or Usual Name: | Irrigation Pump |
| Classification Name: | Neurological Endoscope (21 C.F.R. 882.1480) |
| Regulatory Class: | Class 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 intended to support scientific methods used for Performance - Bench testing of the Hydro Irrigation System.
NOTE 2: The predicate device has not been subject to a design-related recall.
Device Description:
The Hydro Irrigation System is an irrigation device used for cleaning the distal lens of a rigid endoscope to maintain visualization during surgical procedures without removing the endoscope from the surgical site. The Hydro Irrigation System consists of three main components: (1) an irrigation console; (2) an irrigation cassette that inserts into the console, and (3) a foot switch that connects to the console. When actuated, the foot switch signals the console, which controls the operation and flow rate of irrigation fluid to the distal lens at the surgical site. The cassette draws irrigation fluid from the irrigation bag and delivers it to the distal lens through tubing and a connected sheath.
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K253679
The Hydro Irrigation System provides two irrigation modes: Clean, which provides a brief stream over the distal lens of the endoscope to remove debris; and Flush, which delivers a continuous stream to maintain a clear visualization at the surgical site. The Hydro Irrigation System also includes the optional RISE (Reimagined Integrated Surgical Experience) functionality, enabling integration with compatible Stryker devices via ethernet. RISE enhances workflow efficiency and reduces OR clutter by providing an extended user interface for controlling Hydro Console's power and irrigation settings.
# Indications for Use:
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.
Comparison of Technological Characteristics with the Predicate Device:
| Feature | Subject Device | Predicate Device |
| --- | --- | --- |
| | Hydro Irrigation System | Clearvision II Lens Irrigation System |
| Manufacturer | Stryker Instruments | Karl Storz |
| Classification | Class II | Same as subject device |
| Product Code | GWG | Same as subject device |
| Classification Regulation | 21 C.F.R. 882.1480 | Same as subject device |
| Classification Name | Neurological Endoscope | Same as subject device |
| Submission Reference | This submission | K072410 |
| Intended Use | Lens cleaning during endoscopic procedures | Same as subject device |
| Indications for Use | NOTE 1 | NOTE 2 |
| System Components | • Irrigation Console • Disposable Irrigation Cassette Tubing* • Foot Switch *NOTE: Offers front-facing integrated irrigation tube set designed for improved usability. | • Irrigation Console • Disposable Tubing set • Foot Switch |
| Principle of Operation | When actuated, the foot switch signals the console, which controls the operation and flow rate of irrigation fluid to the distal lens at the surgical site. The cassette draws irrigation fluid from the irrigation bag and delivers it to the distal lens through tubing and a connected sheath. | Same as subject device |
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K253679
| Feature | Subject Device | Predicate Device |
| --- | --- | --- |
| | Hydro Irrigation System | Clearvision II Lens Irrigation System |
| Irrigation Modes | • Clean (Brief stream) • Flush (Continuous stream) | • Lens Cleaning (Brief stream) • Continuous Irrigation (Continuous stream) |
| Irrigation Settings User Interface | • Display Screen • Two (2) rotary knobs | A rotary knob |
| Irrigation Console Design | • Microprocessor-controlled peristaltic pump • Irrigation and reverse flow with adjustable flow intervals | Same as subject device |
| Compatible Devices | • Cleaning sheath • Rigid endoscopes • Device Control Console (optional RISE compatibility - K241401) | • Cleaning sheath • Rigid endoscopes |
| Wireless Technology | • 4 Channel RFID | • Not available |
| Safety Standards | • IEC 60601-1 • IEC 60601-1-2 • IEC 60601-1-6 • IEC 60601-4-2 | Same as subject device |
NOTE 1: 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.
NOTE 2: The KSEA Clearvision II is a lens irrigation system for cleaning the distal lens of the telescope and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.
## Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
| --- | --- | --- |
| Packaging and Shelf-Life | In accordance with FDA-recognized voluntary consensus standard ISO 11607-1:2019 (14-530) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 11607-2:2019 (14-531) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ASTM F2096-11:2019 (14-359) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ASTM F1886/F1886M-16 (14-501) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ASTM F88/F88M-23 (14-596) | Pass |
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K253679
| Test | Method | Result |
| --- | --- | --- |
| | In accordance with FDA-recognized voluntary consensus standard ASTM D4169-23 (14-576) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ASTM F1980-21 (14-575) | Pass |
| Biocompatibility | In accordance with FDA-recognized voluntary consensus standard ISO 10993-1:2018 (2-258) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 10993-5:2009 (2-245) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 10993-7:2008 (2-275) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 10993-10:2021 (2-296) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 10993-11:2017 (2-255) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 10993-23:2021 (2-291) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ASTM F756-17 (2-250) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 10993-4: 2017/ AMD1:2025 (2-311) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ASTM F2901-19 (2-265) | Pass |
| Cleaning, Disinfection & Sterilization | In accordance with AAMI TIR12:2020 /(R)2023 (14-602) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ANSI AAMI ST98:2022 (14-583) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 17664-2:2021 (14-579) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 11135:2014 (14-529) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 11737-1:2018/AMD1:2021 (15-577) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 11737-2:2019 (14-540) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ANSI/AAMI ST72:2019 (15-541) | Pass |
| Software | In accordance with FDA-recognized voluntary consensus standard IEC 62304:2006+A1:2015 (13-79) | Pass |
| Cybersecurity | In accordance with FDA Guidance for Industry and Staff - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (June 2025) | Pass |
| EMC, Wireless, Electrical, Mechanical, and Thermal Safety | In accordance with FDA-recognized voluntary consensus standard IEC 60601-1:2020 (19-49) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard IEC/TR 60601-4-2 (19-19) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard AIM Standard 7351731 (19-45) | Pass |
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K253679
| Test | Method | Result |
| --- | --- | --- |
| | In accordance with FDA-recognized voluntary consensus standard IEC 60601-1-2 (19-36) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard IEC 60601-1-6 (5-132) | Pass |
| | FCC 47 CFR Part 15:2025, Radio Frequency Devices | Pass |
| Performance – Bench | In accordance with device input specifications, user needs and intended use | Pass |
| | Design Validation in Simulated Use Environment | Pass |
| | Human Factors and Usability Engineering | Pass |
NOTE: Hydro Irrigation System does not require animal or clinical testing to support the determination of substantial equivalence.
**Conclusions:**
The Hydro Irrigation System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. Performance testing and risk analysis demonstrate that the Hydro Irrigation System is as safe and effective as the predicate device and does not raise new or different questions of safety and/ effectiveness introduced by the Hydro Irrigation System when used as instructed.
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