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Ophthalmic Knife

by Sharpoint, Inc.

510(k) K822112

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 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 · Traditional NumberK822112 Date10 Aug 1982ClearedStatusActive

Recalls

9 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0949-04 FDA Unclassified (pre-2012) initiated 3 Mar 2004
    • Terminated Z-0945-04 FDA Unclassified (pre-2012) initiated 3 Mar 2004
    • Terminated Z-0948-04 FDA Unclassified (pre-2012) initiated 3 Mar 2004
    • Terminated Z-0947-04 FDA Unclassified (pre-2012) initiated 3 Mar 2004
    • Terminated Z-0946-04 FDA Unclassified (pre-2012) initiated 3 Mar 2004
    • Terminated Z-0950-04 FDA Unclassified (pre-2012) initiated 3 Mar 2004

    Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

    • Terminated Z-0026-04 FDA Unclassified (pre-2012) initiated 21 Aug 2003

    text on product handle is incorrect

    • Terminated Z-0918-03 FDA Unclassified (pre-2012) initiated 7 May 2003

    Incorrect handle was used in the manufacture of product 52-2761

    • Terminated Z-0705-03 FDA Unclassified (pre-2012) initiated 7 Jan 2003

    size mislabeled on product handle

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  • Withdrawn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
HNN
Device Class
Class I
Regulation
21 CFR Part 886.4350
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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