Precision S 4K Sinuscope
Device Facts
| Record ID | K253602 |
|---|---|
| Device Name | Precision S 4K Sinuscope |
| Applicant | Stryker Endoscopy |
| Product Code | GWG · Neurology |
| Decision Date | Jun 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1480 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age.
Device Story
Precision S 4K Sinuscope is a rigid, tubular optical instrument for visualization during surgical procedures. Device transmits visible and near-infrared light to illuminate internal anatomy; rigid rod lenses relay images from surgical site to external processing and display systems. Used in OR by surgeons for examination, diagnosis, and therapy. Optional HydroFlow cleaning sheath available for specific lengths. Output provides real-time visualization to assist surgeon in navigating anatomy and performing procedures. Benefits include enhanced visualization during minimally invasive surgeries.
Clinical Evidence
Bench testing only. No clinical or animal data provided. Performance testing included biocompatibility (ISO 10993 series), reprocessing validation (AAMI TIR12, ST98, ST79, ST58, ISO 15883, ISO 17664, ISO 17665, ISO 22441), electrical safety (IEC 60601-1, IEC 60601-2-18), packaging (ASTM D4169), and optical performance (ISO 8600-1). Comparative bench testing against the predicate confirmed equivalent optical characteristics including depth of field, MTF, illumination, and transmission.
Technological Characteristics
Rigid rod lens endoscope; stainless steel working length; distal tip (stainless steel, optical glass, epoxy, glass fibers, solder, copper alloy); PEEK eyepiece. Visible and NIR transmission. Dimensions: 4.0mm/3.1mm OD, 125-180mm WL, 0-70 degree DOV. Reusable; manual/automated cleaning; steam/H2O2 sterilization. Connectivity: optical interface to external display system. No software/algorithm.
Indications for Use
Indicated for otolaryngology, head and neck, rhinology, and endoscopic plastic/reconstructive surgery; minimally invasive cranial neurosurgery in adults and pediatric patients; endonasal skull base surgery in adults and pediatric patients > 6 years of age.
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
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 4, 2026
Stryker Endoscopy
Divya Sekar
Senior Principal, Regulatory Affairs Specialist
5900 Optical Ct.
San Jose, California 95138
Re: K253602
Trade/Device Name: Precision S 4K Sinuscope
Regulation Number: 21 CFR 882.1480
Regulation Name: Neurological Endoscope
Regulatory Class: Class II
Product Code: GWG, EOB
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" (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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253602 - Divya Sekar
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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).
Sincerely,
JULIA E.
SLOCOMB -S
Digitally signed by
JULIA E. SLOCOMB -S
Date: 2026.06.04
16:29:16 -04'00'
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K253602 - Divya Sekar
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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. | K253602 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Precision S 4K Sinuscope | | |
| Please provide your Indications for Use below. | | ? |
| The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery. | | |
| The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age. | | |
| 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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K253602
## 510(k) Summary
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 Endoscopy 5900 Optical Court San Jose, CA 95138 |
| --- | --- |
| Contact Person | Divya Sekar Senior Principal, Regulatory Affairs Specialist Email: divya.sekar@stryker.com Phone: 408-754-2473 |
| Date Prepared | November 17, 2025 |
### **Subject Device:**
| Name of Device: | Precision S 4K Sinuscope |
| --- | --- |
| Common or Usual Name: | Sinuscope |
| Classification Name: | Neurological Endoscope^{1} (21 C.F.R. §882.1480) Nasopharyngoscope (flexible or rigid) and accessories^{2} (21 CFR §874.4760) |
| Regulatory Class: | Class II |
| Product Code: | GWG^{1} |
| Subsequent Product Code: | EOB^{2} |
| 510(k) Review Panel: | Neurology |
$^{1}$When intended for use in neurosurgery procedure.
$^{2}$When intended for use in otolaryngology procedure.
### **Predicate Device(s):**
| Precision S 4K Sinuscope | K211202 (primary), K191102 |
| --- | --- |
*NOTE: The predicate device has not been subject to a design-related recall.*
### **Device Description:**
Stryker’s Precision S 4K Sinuscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during surgical procedures. The Precision S 4K Sinuscope transmits visible and near-infrared light to illuminate and image the anatomy, then relaying the image out of the surgical site for processing and display.
### **Indications for Use:**
The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
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K253602
The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age.
# **Comparison of Technological Characteristics with the Predicate Device:**
| Feature | Subject Device | Predicate Device |
| --- | --- | --- |
| | Precision S 4K Sinuscope | Precision S 4K Sinuscope |
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Submission Reference | Current Submission | K211202 (primary), K191102 |
| Intended Use | Endoscopic illumination and imaging during endoscopic procedures. | Same as subject device |
| Indications for Use Statement | The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age. | Same as subject device |
| **Design** | | |
| Operating Principles | Transmission of light to illuminate and image procedures, then relays the image out of the surgical site for processing and display. | Same as subject device |
| Image Transmission | Rigid rod lenses | Same as subject device |
| Transmission Spectrum | Visible and Near-infrared | Same as subject device |
| Outer Diameter (OD) | 4.0mm, 3.1mm | Same as subject device |
| Working Length (WL) | 125mm – 180mm | Same as subject device |
| Direction of View (DOV) | 0°-70° | Same as subject device |
| Field of View (FOV) | 80° | 80° for 3.1mm Sinuscope 105° for 4.0mm Sinuscope |
| Depth of Field | 7mm – 35mm | Same as subject device |
| Optional Accessories | Precision S HydroFlow Cleaning Sheath (available for 155mm – 180mm WL Sinuscopes) | N/A – No optional accessory |
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K253602
| Feature | Subject Device | Predicate Device |
| --- | --- | --- |
| | Precision S 4K Sinuscope | Precision S 4K Sinuscope |
| **Materials** | | |
| Working Length (patient-contacting) | Stainless steel | Same as subject device |
| Distal Tip (patient-contacting) | Stainless steel, optical glass, epoxy, glass fibers, solder, copper alloy | Same as subject device |
| Main body (non-patient contacting) | Stainless steel, TiAlOx | Same as subject device |
| Eyepiece (non-patient contacting) | Polyetheretherketone (PEEK) | Same as subject device |
| **Processing** | | |
| Single Use or Reusable | Reusable | Same as subject device |
| Cleaning | Manual and Automated | Same as subject device |
| Disinfection | Automated | Same as subject device |
| Sterilization | Steam (Autoclave), Hydrogen Peroxide (Steris, Sterrad) | Same as subject device |
| Sterility Assurance Level | 10^{-6} | Same as subject device |
### **Performance Data:**
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
| --- | --- | --- |
| 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 10993-10:2021 (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 |
| Cleaning, Disinfection & Sterilization (Reprocessing) | 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 ISO 15883-1:2006 + A1:2014 | Pass |
| | In accordance with ISO 15883-2:2006 | Pass |
| | In accordance with ISO 15883-5:2021 | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020, A4:2020 (14-562) | Pass |
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K253602
| Test | Method | Result |
| --- | --- | --- |
| | In accordance with FDA-recognized voluntary consensus standard ANSI AAMI ST58:2024 (14-607) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 17664-1:2021 (14-578) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 17665:2024 (14-601) | Pass |
| | In accordance with FDA-recognized voluntary consensus standard ISO 22441:2022 (14-586) | Pass |
| Electrical 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 60601-2-18:2009 (9-114) | Pass |
| Packaging | In accordance with FDA-recognized voluntary consensus standard ASTM D4169:2022 (14-576) | Pass |
| Optical Performance | In accordance with FDA-recognized voluntary consensus standard ISO 8600-1:2015 (9-110) | Pass |
| Performance – Bench | Sinuscope - Comparative optical performance testing to currently legally marketed predicate device: Depth of Field, Modulated Transfer Function (MTF), Vignetting, Illumination, Optical Transmission, Field of View (FOV), Apparent Field of View (AFOV), Optical Train Concentricity. | Pass |
| | Sinuscope - Fiber Transmission and NIR Wavelength Transmission. | Pass |
| | Sinuscope - Sharp Edge Inspection and Distal Tip Geometry | Pass |
| | Sinuscope - In Focus / Out of Focus Particulates | Pass |
| | Sinuscope – Visual Verification of Transmission Capabilities | Pass |
| | Sinuscope / Cleaning Sheath - Design Validation | Pass |
| | Sinuscope / Cleaning Sheath - Compatibility and Cleaning Performance | Pass |
| | Cleaning Sheath - Fiber transmission, Illumination homogeneity and Bending stiffness | Pass |
*NOTE: Precision S 4K Sinuscope does not require animal or clinical testing to support the determination of substantial equivalence.*
### **Conclusions:**
The Precision S 4K Sinuscope is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the Precision S 4K Sinuscope when used as instructed.
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