← Product Code [EOB](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB) · K965233

# SHARPSITE AC (K965233)

_Xomed, Inc. · EOB · Apr 4, 1997 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K965233

## Device Facts

- **Applicant:** Xomed, Inc.
- **Product Code:** [EOB](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB.md)
- **Decision Date:** Apr 4, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4760
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## 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.

## Regulatory 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

## Submission Summary (Full Text)

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APR - 4 1997 K965233
revised 4/9

# 510(k) Summary

1.0 Date Prepared
December 23, 1996

2.0 Submitter (Contact)
David Timlin
Xomed Surgical Products
Jacksonville, FL
(904) 279-7532

3.0 Device Name
Proprietary Name: SHARPSITE Ac
Common Name(s): Rigid Rod Lens Endoscopes
Classification Name: Endoscope, rigid
Nasopharyngoscope (flexible or rigid)

5.0 Device Classification
Endoscope, rigid
Procode 78GCM
Class II; 21 CFR 876.1500
Tier 2
Nasopharyngoscope
Procode 77EOB
Class II; 21 CFR 874.4760
Tier 2
(flexible or rigid)

6.0 Device Description
The SHARPSITE Ac endoscopes are a series of small diameter, rigid rod lens endoscopes; available in diameters of 2.7mm, 4.0mm and 5.0mm with tip angles of 0, 30 and 70 degrees. The length of the scopes range from 175mm to 188 mm. Each scope is fitted with a removable light port adapter for use with light cables from different manufacturers.

7.0 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.

8.0 Substantial Equivalence
Substantial equivalency is based on the fact that the SHARPSITE Ac endoscopes are equivalent to current Xomed endoscopes in their intended use and materials. They are likewise equivalent in design, intended use and performance claims to sinuscopes currently marketed by Smith & Nephew (S&N) ENT.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K965233](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K965233)

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