Skip to content

Eye Procedure Pack

by Marwood Medical, Inc.

510(k) K850340

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 NumberK850340 Date22 May 1985ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 886.4790
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Eye Procedure Pack is an ophthalmic device containing an ophthalmic sponge. It is designed to assist in the management of fluids or tissues during ophthalmic procedures.

This device is supplied by Marwood Medical, Inc. and has received FDA 510k clearance. It is classified as a class 2 medical device under regulation number 886.4790.

Other devices from Marwood Medical, Inc.