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Stryker 1488 HD Video Camera with Infrared Compatibility

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132785

by Stryker Endoscopy

Identifiers

510(k) Number
K132785 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stryker 1488 HD Video Camera with Infrared Compatibility is an endoscopic camera system designed to produce still and video images in the surgical field during surgical endoscopic procedures. It utilizes CMOS technology and is sensitive in both the visible and infrared spectrum, allowing for enhanced imaging across various surgical specialties. The device supports cross-specialty standardization and is enabled through nine dedicated surgical specialty settings.

This single-use device is supplied as a camera system that interfaces with a variety of rigid and flexible scopes to transfer optical images from the surgical site to the camera head. It is intended for use in endoscopic settings and is stored according to manufacturer specifications. The device is regulated under FDA 510(k) authorization with clearance type Traditional and was reviewed under advisory committee categories including Gastroenterology, Urology, and GU.

Frequently asked questions

What surgical specialties can benefit from the Stryker 1488 infrared‑compatible camera?

The camera includes nine dedicated settings that cover gastroenterology, urology, and other general urologic (GU) procedures, allowing clinicians to standardize imaging across multiple specialties while taking advantage of infrared sensitivity for enhanced tissue contrast.

Is the Stryker 1488 camera reusable or single‑use?

It is supplied as a single‑use system. This eliminates the need for reprocessing, reduces cross‑contamination risk, and ensures consistent image quality for each procedure.

What types of endoscopes can be connected to the 1488 camera system?

The device is designed to interface with both rigid and flexible scopes, transferring optical images from the surgical site to the camera head regardless of the scope’s shape or diameter.

How should the camera be stored before use?

The camera must be stored according to the manufacturer’s specifications, which typically involve a controlled environment to protect the CMOS sensor and infrared components from moisture and extreme temperatures.

What regulatory pathway was used for the Stryker 1488 camera?

The device was cleared through the FDA 510(k) process with a Traditional clearance type, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 1488 HD 3-Chip camera system - Stryker, Stryker 1488 Hd Video Camera With Infrared Compatibility (K132785 ..., Camera systems - Stryker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker Endoscopy

Sources (1)

  • FDA 510(k) K132785 24 fields · synced Sep 21, 2026