CMOS Video Esophagoscope SSU
510(k) K192523
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192523 | Date24 Jan 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOX
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4710
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CMOS Video Esophagoscope SSU is a flexible esophagoscope designed for endoscopic visualization of anatomical structures. It provides real-time imaging of the nasal sinuses, larynx, esophagus, and gastroesophageal junction during diagnostic procedures, enabling precise examination of these regions.
This single-use device is intended for use in clinical settings by trained professionals in the field of Ear, Nose, and Throat (ENT) medicine. It operates with an E-Box adaptor for connection to compatible imaging systems, such as the CCU, and is classified under FDA product code EOX as a Class II device. The device holds an FDA 510(k) clearance for substantial equivalence and is regulated under regulation number 874.4710.
Other devices from Karl Storz SE & CO. KG
Questions
AI-generated answers, 1 Oct 2026
What is the CMOS Video Esophagoscope SSU used for?
The CMOS Video Esophagoscope SSU is a flexible, single-use endoscope designed specifically for diagnostic procedures in Ear, Nose, and Throat (ENT) medicine. It enables real-time visualization of anatomical structures such as the nasal sinuses, larynx, esophagus, and gastroesophageal junction. This allows clinicians to perform precise examinations of these regions during procedures, improving diagnostic accuracy and patient care.
How is the CMOS Video Esophagoscope SSU supplied and what does it require for use?
The CMOS Video Esophagoscope SSU is supplied as a single-use device, meaning each unit is intended for one procedure only. To operate, it must be connected to a compatible imaging system via an E-Box adaptor. This adaptor ensures the device integrates seamlessly with systems like the CCU for high-quality imaging during examinations.
Is the CMOS Video Esophagoscope SSU sterile and how should it be stored?
The CMOS Video Esophagoscope SSU is a sterile, single-use device, ensuring safety and hygiene for each procedure. It should be stored in its original packaging in a clean, dry environment, protected from direct sunlight and extreme temperatures. Proper storage maintains sterility and device integrity until use.
What regulatory approval does the CMOS Video Esophagoscope SSU hold?
The CMOS Video Esophagoscope SSU holds FDA 510(k) clearance, demonstrating substantial equivalence to a predicate device. It is classified under FDA product code EOX as a Class II medical device, regulated under regulation number 874.4710. This clearance ensures it meets established safety and performance standards for use in clinical settings.
Are there different sizes or models of the CMOS Video Esophagoscope SSU?
The CMOS Video Esophagoscope SSU is a specific model designed for flexible endoscopic procedures. While the provided data does not list multiple sizes or variants, its flexible design allows for versatile use in ENT examinations. For exact specifications, refer to the device’s technical documentation or consult Karl Storz SE & CO. KG for detailed product variations.