Ksea Reverse Video
by Karl Storz Endoscopy-America, Inc. 510(k)
Active
510(k) K952482
Overview
The KSEA Reverse Video is an endoscopic video imaging system/component designed for use in gastroenterology and urology procedures. It provides real-time visualisation of internal anatomical structures, facilitating diagnostic and therapeutic interventions within the gastrointestinal and urinary tracts. The device integrates with endoscopes to capture high-quality video images, enabling precise navigation and assessment during procedures.
This system is intended for single-use or reusable applications, depending on the specific model and accessories used, and is regulated under FDA 510(k) clearance (K952482) with a classification under regulation 876.1500. It is supplied as part of an endoscopic imaging system and is compatible with standard endoscopy settings. The device is not MRI-safe, and its sterility or reprocessing instructions are determined by the manufacturer’s accompanying documentation. Multiple registration numbers and FEI numbers indicate its use across various endoscopic procedures in the specified medical specialties.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952482 | Date23 Oct 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FET
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Karl Storz Endoscopy-America, Inc.
Questions
What is the KSEA Reverse Video used for?
The KSEA Reverse Video is an endoscopic video imaging system designed specifically for gastroenterology and urology procedures. It provides real-time visualization of internal anatomical structures within the gastrointestinal and urinary tracts, enabling clinicians to perform diagnostic evaluations and therapeutic interventions with greater accuracy. By integrating with endoscopes, it captures high-quality video images, aiding in precise navigation and assessment during procedures.
How is the KSEA Reverse Video supplied, and what are its usage options?
The KSEA Reverse Video is supplied as part of an endoscopic imaging system and is compatible with standard endoscopy settings. It can be used for either single-use or reusable applications, depending on the specific model and accessories selected. The manufacturer’s accompanying documentation will outline the appropriate sterility and reprocessing instructions for reusable components.
Is the KSEA Reverse Video safe for MRI environments?
No, the KSEA Reverse Video is explicitly stated as not MRI-safe. Clinicians should ensure the device is not used in MRI environments to avoid potential risks associated with magnetic fields.
What regulatory approvals does the KSEA Reverse Video hold?
The KSEA Reverse Video holds FDA 510(k) clearance under the classification of regulation 876.1500. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable regulatory standards for endoscopic video imaging systems in gastroenterology and urology.
What specialties primarily utilize the KSEA Reverse Video?
The KSEA Reverse Video is primarily utilized in gastroenterology and urology specialties. Its design and functionality are tailored to support diagnostic and therapeutic procedures within the gastrointestinal and urinary tracts, making it a versatile tool for these medical fields.