CMOS Video Rhino-Laryngoscope SSU
510(k) K192090
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK192090 | Date27 Jan 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- EOB
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The CMOS Video Rhino-Laryngoscope SSU is a rigid nasopharyngoscope, designed for visual examination of the nasal passages, nasopharynx, and larynx. It integrates a CMOS sensor for high-resolution imaging, enabling detailed assessment of anatomical structures in otolaryngology procedures.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as otolaryngology offices and hospitals. It is classified under FDA device class II and has received FDA 510(k) clearance, along with MDR authorization. The device is available in a 3.5 mm diameter configuration with a 30 cm length, and its sterility and MRI safety must be verified prior to use as per regulatory guidelines.
Other devices from Karl Storz SE & CO. KG
Questions
AI-generated answers, 18 Sep 2026
What is the primary use case for the CMOS Video Rhino-Laryngoscope SSU in clinical practice?
The CMOS Video Rhino-Laryngoscope SSU is specifically designed for visual examination of the nasal passages, nasopharynx, and larynx. Its integrated CMOS sensor enables high-resolution imaging, making it ideal for detailed otolaryngology assessments in clinical settings like hospitals and ENT offices.
Is this device single-use or reusable, and what does that mean for my workflow?
The CMOS Video Rhino-Laryngoscope SSU is a reusable medical instrument. This means it must be properly cleaned, disinfected, and sterilized between uses according to established protocols to ensure patient safety and device longevity.
What size and length options are available for this device, and how might that affect my procedure?
The device is available in a single configuration: a 3.5 mm diameter with a 30 cm length. This design is optimized for accessing the nasal passages, nasopharynx, and larynx, ensuring flexibility for standard ENT examinations while maintaining precision.
How should I verify the sterility and MRI safety of this device before use?
Sterility and MRI safety must be verified prior to use as per regulatory guidelines. Since it is reusable, ensure proper cleaning, disinfection, and sterilization processes are followed. For MRI safety, confirm compatibility with your facility’s MRI protocols, as the device may require specific checks depending on its materials and construction.
What regulatory pathways has this device undergone, and how does that impact its use?
The device has received FDA 510(k) clearance under the Traditional 510(k) Review pathway, classified as Class II, and holds MDR authorization. This means it has been evaluated for safety and effectiveness by regulatory bodies, ensuring it meets established standards for reusable rigid nasopharyngoscopes in otolaryngology.