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Medisiss Phacoemulsification Tips/Needles

by Surgical Instruments Service and Savings, Inc.

510(k) K030179

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Abbreviated NumberK030179 Date24 Jan 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1642-2013 FDA Class II initiated 3 May 2013

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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  • Withdrawn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
NKX
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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