Flexible Fiber-Optic Nasopharyngoscope

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

510(k) Number

K895245 ↗

FDA Product Code

EOB

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K955275 Active Cleared 4 Nov 1996

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See all devices from Optimed Technologies, Inc. →

• Is this nasopharyngoscope designed for single-use or reusable applications, and what does that mean for maintenance?

  The Flexible Fiber-Optic Nasopharyngoscope is explicitly supplied as a reusable device. This means it must undergo thorough cleaning, sterilization, and regular maintenance between uses to ensure safety and functionality. Proper reprocessing is critical to prevent cross-contamination and preserve the fiber-optic clarity for accurate diagnostic imaging.

• What types of healthcare professionals are intended to use this device, and why is that relevant?

  This device is intended for use by trained healthcare professionals, specifically otolaryngologists, as noted in the description. This specialization ensures that only qualified practitioners—who have experience in nasal and upper airway examinations—operate the nasopharyngoscope, reducing risks of misuse or misdiagnosis.

• Are there multiple sizes or models available for this nasopharyngoscope, and how might that affect my purchase decision?

  The data lists multiple registration numbers and FEI numbers, which typically correspond to different models or variations of the device. While exact specifications (e.g., length, diameter, or tip flexibility) aren’t detailed here, the variety suggests options may exist to accommodate different patient anatomies or clinical preferences. Contacting the manufacturer would clarify which models align with your needs.

• How is the regulatory pathway for this device structured, and what does that imply for compliance?

  The device holds an FDA 510(k) clearance (K895245) under 21 CFR 874.4760, classified as a Class II medical device. This means it has been deemed substantially equivalent to a predicate device and must comply with FDA requirements for design controls, labeling, and post-market surveillance. Purchasers should ensure their facility adheres to these regulations for proper use and documentation.

• What medical specialty is primarily associated with this device, and why does that matter for clinical workflows?

  The device is categorized under Ear, Nose, and Throat (ENT) medical specialty, as indicated in the data. This specialization ensures the nasopharyngoscope is tailored for procedures involving the nasal passages, nasopharynx, and adjacent structures—critical for diagnosing conditions like sinusitis, nasal polyps, or upper airway obstructions. Clinicians in ENT practices will find it most relevant to their workflows.