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Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80cc, Ivalon Eye Drain, 400cc, Ivalon Eye Wick

by M-Pact Worldwide Management Corp.

510(k) K971832

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK971832 Date31 Jul 1997ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0798-2025 FDA Class II initiated 22 Oct 2024
    • Ongoing Z-0799-2025 FDA Class II initiated 22 Oct 2024

    Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

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  • Withdrawn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

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