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KSEA Clearvision Lens Irrigation System

by Karl Storz Endoscopy-America, Inc.

510(k) K013838

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 NumberK013838 Date16 Jan 2002ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The KSEA Clearvision Lens Irrigation System is a microprocessor-controlled pump system designed for endoscopic lens irrigation. It is used during sinus surgery to clean objective lenses and remove residual solution without scope removal.

The system is supplied as a single-use device and is regulated under FDA 510(k) clearance with product code EOB. It is intended for use in ear, nose, and throat procedures and is manufactured by Karl Storz Endoscopy-America, Inc.

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Questions

AI-generated answers, 6 Oct 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 KSEA ClearVision Lens Irrigation System used for?

    The KSEA ClearVision Lens Irrigation System is a microprocessor-controlled pump system designed for endoscopic lens irrigation during sinus surgery. It is used to clean objective lenses and remove residual solution without requiring scope removal.

  • Is the KSEA ClearVision Lens Irrigation System single-use or reusable?

    The KSEA ClearVision Lens Irrigation System is supplied as a single-use device. It is not intended to be reused after a single procedure to ensure patient safety and device performance.

  • What procedures is the KSEA ClearVision Lens Irrigation System intended for?

    The system is specifically intended for use in ear, nose, and throat (ENT) procedures, particularly during sinus surgery where maintaining clear visualization of the surgical field is critical.

  • What is the regulatory status of the KSEA ClearVision Lens Irrigation System?

    The KSEA ClearVision Lens Irrigation System is regulated under FDA 510(k) clearance with product code EOB. It has been determined to be substantially equivalent to predicate devices for its intended use in ENT procedures.