LogoFDA 510(k) Search
K Number
K030572
Device Name
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
Manufacturer
HENKE SASS WOLF OF AMERICA, INC.
Date Cleared
2003-04-01

(36 days)

Product Code
EOB
Regulation Number
874.4760
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.

Device Description

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device.

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a Nasopharyngoscope. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format of AI/ML device performance.

The document primarily focuses on:

  • Regulatory clearance: The FDA's determination that the Henke Sass Wolf of America Nasopharyngoscope is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
  • Device classification: Class II, product code EOB.
  • Intended use: To examine or treat the nasal cavity and nasal pharynx, specifically between the upper respiratory tracts of the nasal passage and the vocal cords.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. This type of information is typically found in accompanying technical documentation or clinical study reports, which are not included here.

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.