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The Fugo Blade

by Medisurg, Ltd.

510(k) K001498

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001498 Date10 Aug 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1224-06 FDA Unclassified (pre-2012) initiated 28 Apr 2006

    No documentation to support shelf life/sterility

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  • Withdrawn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
NCR
FDA applicant
Medisurg , Ltd.
Device Class
Class II
Regulation
21 CFR Part 886.4100
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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