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Alcon Surgical Sponge

by Alcon Laboratories, Inc.

510(k) K896004

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 NumberK896004 Date2 Nov 1989ClearedStatusActive

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  • Withdrawn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
HOZ
FDA applicant
Alcon Laboratories
Device class
Class II
Regulation
21 CFR Part 886.4790
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Alcon Surgical Sponge is an ophthalmic sponge, classified as a class 2 device. It is substantially equivalent to other devices on the market and has been assigned the product code HOZ.

The Alcon Surgical Sponge is supplied as a single-use device and is intended for use in ophthalmic surgical procedures. It has been cleared by the FDA under the 510(k) clearance process, with the clearance number K896004, and is regulated under the regulation number 886.4790. The device is available in various sizes and is stored in envelopes, with 10 envelopes per box and 25 boxes per case.

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