510(k) Report

FDA applicant

Sharpoint, Inc.

Walker, MI9 decisions1982–19869 recalls

FDA records 9 decisions for Sharpoint, Inc. (Walker, MI) from 1982 to 1986: 9 510(k) clearances. Most are in product codes HNN (Knife, Ophthalmic) and HNY (Cystotome). 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Sharpoint, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sharpoint, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sharpoint, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HNNKnife, Ophthalmic3decisions
  • HNYCystotome2decisions
  • GABNeedle, Suturing, Disposable1decision
  • EMFKnife, Surgical1decision
  • JYOKnife, Ear1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K822112Ophthalmic KnifeSharpoint, Inc. · 19821cites it

What has FDA decided for it lately?

  • K863595Coated Suture NeedleSharpoint, Inc. · 1986
  • K861947Surgical KnifeSharpoint, Inc. · 1986
  • K840764Ear KnivesSharpoint, Inc. · 1984
  • K840855Corneal Scleral LanceSharpoint, Inc. · 1984
  • K840660Posterior Capsulotomy CystitomeSharpoint, Inc. · 1984
  • K840659Anterior Capsulectomy CystitomeSharpoint, Inc. · 1984
  • K830522Stainless Steel Suture 316LSharpoint, Inc. · 1983
  • K822112Ophthalmic KnifeSharpoint, Inc. · 19829 recalls

All 9 as Sharpoint, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K822112Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm…Mar 3, 2004
  • K822112Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm…Mar 3, 2004
  • K822112Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full…Mar 3, 2004
  • K822112Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm…Mar 3, 2004
  • K822112Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full…Mar 3, 2004
  • K822112Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled…Mar 3, 2004