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Ecleris Sinuscope

by Ecleris USA

510(k) K131323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131323 Date9 Jun 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOB
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ecleris Sinuscope is a nasopharyngoscope, available in rigid configurations, designed to provide illumination and direct visualization of the nasal cavity. It functions as an optical instrument to assist physicians during diagnostic and therapeutic ear, nose, and throat procedures.

This device is a reusable instrument that has received FDA 510(k) clearance. It is supplied in various specifications, including 3mm and 4mm diameters, with some models designated as autoclavable and others as non-autoclavable.

Other devices from Ecleris USA

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Ecleris Sinuscope?

    The Ecleris Sinuscope is an optical instrument designed to provide illumination and direct visualization of the nasal cavity, assisting physicians during diagnostic and therapeutic ear, nose, and throat procedures.

  • Is the Ecleris Sinuscope a single-use or reusable device?

    The Ecleris Sinuscope is a reusable instrument. It is available in different configurations, including models that are autoclavable and others that are non-autoclavable.

  • What size options are available for this sinuscope?

    The device is supplied in various specifications, including 3mm and 4mm diameter options to accommodate different clinical requirements.

  • Has this device received regulatory authorization?

    Yes, the Ecleris Sinuscope has received FDA 510(k) clearance for use as a nasopharyngoscope.