Model ENT-4L-FLEXIBLE Nasopharyngoscope

Full name

Model Ent-4l-Flexible Nasopharyngo-

510(k) Number

K821182 ↗

FDA Product Code

EQN

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Flexible Nasopharyngo-Laryngoscope #

  Class II

  FDA 510(k) K821181 Active Cleared 13 May 1982

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  FDA 510(k) K811943 Active Cleared 28 Jul 1981

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  FDA 510(k) K854581 Active Cleared 28 Feb 1986

• Machida Flexible Intubation Scope Fls-P

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  FDA 510(k) K812734 Active Cleared 19 Oct 1981

• Machida America Model Ac-5000 Automatic Disinfect.

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  FDA 510(k) K871712 Active Cleared 14 Jan 1988

• Machida Flexible Nasopharyngo-Laryngoscope Fns-1

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  FDA 510(k) K844834 Active Cleared 11 Jun 1985

See all devices from Machida America, Inc. →

• What is the primary use of the Model ENT-4L-Flexible Nasopharyngoscope in clinical practice?

  The Model ENT-4L-Flexible Nasopharyngoscope is designed for visual examination of the nasal passages, nasopharynx, and adjacent structures. It allows healthcare professionals to directly visualize the upper airway and surrounding anatomy, which is useful for diagnostic evaluations or procedural guidance in otolaryngology.

• Is this device intended for single-use or reusable applications?

  This device is explicitly supplied as a reusable medical device, meaning it is intended for repeated use in clinical settings after proper cleaning, disinfection, and sterilization. It is not designed for single-use.

• How was the regulatory pathway for this device determined, and what does that mean for its use?

  The device was granted FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE) by the Ear, Nose, and Throat (ENT) Advisory Committee. This means the FDA determined it is as safe and effective as a legally marketed predicate device, confirming its suitability for use in otolaryngology procedures.

• What types of clinical specialties would most commonly utilize this nasopharyngoscope?

  This device is specifically categorized under Ear, Nose, and Throat (ENT) medical specialty, making it most commonly used by otolaryngologists, ENT surgeons, and other specialists who perform examinations or procedures involving the nasal passages, nasopharynx, and upper airway.

• Are there multiple models or variations of this nasopharyngoscope, or is this a single standardized device?

  The provided data lists multiple registration numbers (e.g., 3003761012, 3005747797, etc.) under the same device classification, suggesting there may be variations or different lots/models of the ENT-4L-Flexible Nasopharyngoscope in circulation. However, the core design remains consistent as a flexible nasopharyngoscope for ENT use.