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K Number
K972450
Device Name
FLEXTIP GRASPER
Manufacturer
ENDIUS, INC.
Date Cleared
1997-11-21

(144 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 FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.

Device Description

The Endius Incorporated FlexTip™ Grasper is composed of:

  • · a tissue engaging tip of either a through cut or biting design
  • · a series of nested high density polycarbonate vertebra joints which allow articulation of the grasper tip
  • a shaft section which connects the flexible end to the handle .
  • · a radius control sheath used to control the radius of curvature of the flexible tip
  • · a pistol grip handle containing the control mechanism for the grasper tip.
AI/ML Overview

The provided text is a 510(k) summary for the FlexTip™ Grasper, which is a manual surgical instrument. It describes the device, its intended use, and its technological characteristics compared to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study from the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval, rather than presenting a performance study against specific 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.