Endoscopic Camera

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991416 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Genzyme Surgical Product (Genzyme Biosurgery) →

• What is the Endoscopic Camera used for in clinical settings?

  The Endoscopic Camera is designed to attach to standard endoscopes for real-time visualization of internal body cavities, hollow organs, and anatomical canals. It provides high-resolution imaging to assist clinicians in diagnostic assessments and procedural guidance, particularly in gastroenterology and urology. The modular design ensures seamless integration with existing endoscopic systems, enhancing clarity and detail for accurate clinical evaluation.

• How is the Endoscopic Camera supplied and intended for use?

  The Endoscopic Camera is supplied as a reusable medical instrument, intended for use in controlled clinical environments such as operating rooms, endoscopy suites, and diagnostic centers. Its reusable nature requires adherence to strict cleaning, disinfection, and maintenance protocols as outlined by the manufacturer to ensure sterility and optimal functionality. This design supports long-term use across multiple procedures.

• What configurations are available for the Endoscopic Camera?

  The Endoscopic Camera is available in two configurations: RGB and 3-Chip Digital RGB. Both configurations deliver high-resolution imaging, but the 3-Chip Digital RGB variant may offer enhanced color accuracy and detail for specialized clinical applications. The choice between configurations depends on the specific requirements of the endoscopic procedure and the existing system compatibility.

• Does the Endoscopic Camera have any special storage or handling requirements?

  While the device data does not specify unique storage requirements beyond standard medical device protocols, the reusable nature of the Endoscopic Camera necessitates careful handling to prevent contamination. It should be stored in a clean, dry environment, protected from physical damage, and maintained according to manufacturer guidelines. Proper storage ensures longevity and readiness for use in clinical settings.

• What regulatory pathway and clearance does the Endoscopic Camera follow?

  The Endoscopic Camera holds FDA 510(k) clearance (K991416) under the Traditional pathway, categorized under product code GCJ for General & Plastic Surgery applications. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring compliance with regulatory standards for safety and effectiveness in its intended use.