SHARPSITE AC
Device Facts
| Record ID | K965233 |
|---|---|
| Device Name | SHARPSITE AC |
| Applicant | Xomed, Inc. |
| Product Code | EOB · Ear, Nose, Throat |
| Decision Date | Apr 4, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4760 |
| Device Class | Class 2 |
Intended Use
The Xomed SHARPSITE Ac rigid rod lens endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
Device Story
SHARPSITE Ac: series of rigid rod lens endoscopes; diameters 2.7mm, 4.0mm, 5.0mm; tip angles 0, 30, 70 degrees; lengths 175mm-188mm. Features removable light port adapter for compatibility with various light cables. Used by surgeons in otolaryngology, head/neck, rhinology, and plastic/reconstructive surgery settings. Provides optical visualization of internal anatomy to assist surgical procedures.
Clinical Evidence
Bench testing only.
Technological Characteristics
Rigid rod lens endoscope; diameters 2.7mm, 4.0mm, 5.0mm; tip angles 0, 30, 70 degrees; lengths 175mm-188mm; removable light port adapter.
Indications for Use
Indicated for surgical imaging in otolaryngology, Head and Neck procedures, rhinology, and endoscopic plastic and reconstructive surgery.
Regulatory Classification
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.
Predicate Devices
- Xomed endoscopes
- Smith & Nephew (S&N) ENT sinuscopes
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