The 1688 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1688 4K Camera System with Advanced Imaging Modality is indicated for adults and pediatric patients.

A few examples of the more common endoscope surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

1788 Camera 4K Camera System with Advanced Imaging Modality:

The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery whenever a laparoscope/ endoscope/arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.

Device Description

Stryker's Advanced Imaging Modality (AIM) System includes the 1688 4K Camera System with AIM and 1788 4K Camera System with AIM, which are endoscopic camera systems that produces live video in the surgical field during surgical endoscopic procedures.

The 1688 4K Camera System with AIM is sensitive in the visible white light and infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1788 4K Camera System with AIM is sensitive in the visible white light, infrared spectrums and short blue spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 and 1788 4K Camera Systems consist of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - K260185

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.0 8 . 0 3
Silver Spring, MD 20993
www.fda.gov

February 18, 2026

Stryker Endoscopy
Divya Sekar
Senior Principal, Regulatory Affairs Specialist
5900 Optical Ct.
San Jose, California 95138

Re: K260185
Trade/Device Name: 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: January 21, 2026
Received: January 21, 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.

Page 2

K260185 - Divya Sekar Page 2

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).

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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-

Page 3

K260185 - Divya Sekar Page 3

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,

TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2026.02.18 21:31:02 -05'00'

Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

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.
K260185

Please provide the device trade name(s).
1688 4K Camera System with Advanced Imaging Modality;
1788 4K Camera System with Advanced Imaging Modality

Please provide your Indications for Use below.

1688 Camera 4K Camera System with Advanced Imaging Modality:

The users of the 1688 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

1788 Camera 4K Camera System with Advanced Imaging Modality:

The users of the 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

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)

Page 5

Page 1 of 4
K260185

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(a).

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: February 6, 2026

Subject Device(s):

Field	1688 4K Camera System	1788 4K Camera System
Name of Device:	1688 4K Camera System with Advanced Imaging Modality	1788 4K Camera System with Advanced Imaging Modality
Common or Usual Name	3-chip Video Camera	3-chip Video Camera
Medical Specialty	Gastroenterology & Urology	Gastroenterology & Urology
Regulation Number and Name:	Endoscope and accessories (21 C.F.R. §876.1500)	Endoscope and accessories (21 C.F.R. §876.1500)
Regulatory Class:	II	II
Product Code:	GCJ	GCJ
Review Panel:	General & Plastic Surgery	General & Plastic Surgery

Page 6

Page 2 of 4
K260185

Predicate Device(s):

Device	510(k) Number
1688 4K Camera System with Advanced Imaging Modality	K240174
1788 4K Camera System with Advanced Imaging Modality	K233327

Device Description:

Indications for Use:

1688 Camera 4K Camera System with Advanced Imaging Modality:

Page 7

Page 3 of 4
K260185

1788 Camera 4K Camera System with Advanced Imaging Modality:

The indications for use statement for the subject devices has been modified from that of the predicate devices to include "spine surgery." However, this modification does not result in a new intended use, nor does it affect the safety or effectiveness of the device relative to the predicate devices as "spine surgery" is considered a sub-specialty of the previously cleared indication "neurosurgery." Furthermore, the cleared indications for use for the predicate devices include "laparoscopic and thoracoscopic anterior spinal fusion" and "decompression fixation," which are commonly recognized as spine surgeries.

Comparison of Technological Characteristics with Predicate Device(s):

Item	Subject Devices	Predicate Devices
	1688 4K Camera Systems with Advanced Imaging Modality	1788 4K Camera Systems with Advanced Imaging Modality
Manufacturer	Stryker	Same as subject devices
Submission Reference	Current submission	K240174
Intended Use	Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures.	Same as subject devices
Imaging Modes	• White Light• Near-infrared fluorescence• Near-infrared transillumination	• White Light• Near-infrared fluorescence• Near-infrared transillumination• Narrow band illumination

Page 8

Page 4 of 4
K260185

Item	Subject Devices	Predicate Devices
	1688 4K Camera Systems with Advanced Imaging Modality	1788 4K Camera Systems with Advanced Imaging Modality
Principles of Operations	Via an endoscope and coupler, light is projected onto one or more complementary metal oxide semiconductor image sensors which acquire a continuous stream of image data. The image data is processed to provide a video stream that is then sent to a display for viewing.	Same as subject devices
Camera System Components	• Camera Control Unit• Camera Head• Coupler	Same as subject devices
Safety Standards	• IEC 60601-1• IEC 60601-1-6• IEC 60601-2-18• IEC 60601-1-2• IEC 60601-4-2	Same as subject devices
Mode of Operation	• Alternate Frame Processing• Simultaneous Frame Processing	Same as subject devices
Image Sensor	• CMOS image sensor	Same as subject devices
Image Processing/ Video Output	• Digital	Same as subject devices
Resolution	• 4K (up to 3840 x 2160)	Same as subject devices
Frame Rate	• 60 frames per second	Same as subject devices
Endoscope Compatibility	• Compatible with endoscopes that conform to ISO/TS 18339	Same as subject devices

Non-Clinical and/or Clinical Tests Summary & Conclusions:

There were no design changes needed or conducted to support the change in indications for use for the 1688 4K Camera System with AIM and 1788 4K Camera System with AIM. The risk-based assessment demonstrated that the change to specify spine surgery neither introduces new risks nor significantly modifies existing risks including risk score, risk acceptability category, or duration of risk. The overall risk profile remains the same. As such, there was no requirement for additional performance testing. Therefore, we conclude that the 1688 and 1788 4K Camera Systems with AIM are as safe and as effective as the legally marketed predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.