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K Number
K963757
Device Name
IRRIGATION/SUCTION HANDLE AND SHEATH
Manufacturer
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Date Cleared
1996-11-26

(69 days)

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

The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for rities mass frightin - Subtron - Subtity, a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity.

The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. One such procedure is the VideoHydrascopic technique developed by Daniel Schuman. MD

Device Description

The irrigation / suction handle with sheath allows the insertion of a 4 0mm telescope and provides the physician the ability to view, apply irrigation fluids, and suction the cavity.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, or any of the other requested details regarding a medical device. The document is a 510(k) Summary for an "Irrigation/Suction Handle with sheath" from 1996, and it explicitly states:

  • "No performance data was obtained."
  • "No clinical tests were performed."

The document focuses on establishing substantial equivalence to previously marketed devices based on technological characteristics and intended use, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer any of the questions about a study showing the device meets acceptance criteria.

§ 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.