1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit
by Stryker
510(k) K200310
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200310 | Date6 Mar 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 1688 Pendulum 4K Camera Head with Integrated Coupler and 1688 4K Camera Control Unit form a high-definition endoscopic imaging system designed for advanced visualisation in minimally invasive procedures. This device combines a lightweight camera head with a central control unit, delivering 4K resolution across five imaging modalities, including visible and infrared spectrums. The camera head features an automatic image flip function to maintain orientation during use. Intended for use in urology and gastroenterology, it provides enhanced clarity for diagnostic and surgical applications.
The system is supplied as a reusable medical device, intended for use in controlled clinical environments such as operating rooms and endoscopy suites. The camera head and control unit are designed for integration with compatible endoscopes, ensuring compatibility with MRI-safe procedures where applicable. Storage and handling follow standard sterile or non-sterile medical device protocols, depending on procedural requirements. Authorised for commercial distribution in the United States under an FDA 510(k) clearance (K200310), this device adheres to regulatory standards for endoscopic imaging systems.
Other devices from Stryker Corp.
Questions
AI-generated answers, 1 Oct 2026
What procedures is the 1688 4K Camera System designed for?
This system is specifically engineered for advanced visualisation in minimally invasive procedures within urology and gastroenterology. Its 4K resolution and five imaging modalities—including visible and infrared spectrums—provide enhanced clarity for both diagnostic evaluations and surgical interventions, ensuring better precision in these specialties.
Is the 1688 4K Camera System reusable or single-use?
The 1688 4K Camera System is designed as a reusable medical device. It is intended for use in controlled clinical environments like operating rooms and endoscopy suites, where proper cleaning, disinfection, and maintenance protocols are followed to ensure safety and performance across multiple procedures.
What imaging modalities does the system support?
The system supports five imaging modalities, including standard visible light and infrared spectrum imaging. This versatility allows clinicians to adapt the camera to different procedural needs, such as enhanced tissue visualization or thermal imaging, depending on the clinical context.
Can the 1688 4K Camera System be used with MRI-safe endoscopes?
Yes, the camera head and control unit are designed for integration with compatible MRI-safe endoscopes where applicable. This ensures flexibility for procedures requiring MRI compatibility, though the specific endoscope must meet MRI safety standards for the system to function safely in such environments.
How should the 1688 4K Camera System be stored and handled?
Storage and handling follow standard protocols for reusable medical devices, depending on whether the system is used in sterile or non-sterile procedures. The camera head and control unit should be cleaned, disinfected, and stored in a clean, dry environment to maintain functionality and prevent contamination between uses.