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Entravision EP-500 I/A Ecco Pack

by Entravision, Inc. 510(k)

Active United States

510(k) K862064

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862064 Date19 Jun 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

This device is a unit for phacofragmentation, used in ophthalmic procedures. It is designed for irrigation and aspiration during cataract surgery.

It is supplied as a reusable system and was cleared via the FDA 510(k) process under K862064. The device is classified as Class II and is intended for use in clinical settings by trained professionals.

Other devices from Entravision, Inc.

Questions

AI-generated answers, 21 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 ENTRAVISION EP-500 I/A ECCO PACK used for?

    This device is used for irrigation and aspiration during cataract surgery, specifically designed for phacofragmentation in ophthalmic procedures to remove lens material while maintaining anterior chamber stability.

  • Is the ENTRAVISION EP-500 I/A ECCO PACK reusable or single-use?

    The device is supplied as a reusable system, meaning it can be cleaned, sterilized, and used multiple times in clinical settings by trained professionals following appropriate reprocessing protocols.

  • How was the ENTRAVISION EP-500 I/A ECCO PACK cleared for market?

    It was cleared via the FDA 510(k) traditional process under submission K862064, demonstrating substantial equivalence to a legally marketed predicate device for the same intended use in phacofragmentation.