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Sharpoint, Inc.

Also registered as Sharppoint, Inc.

United StatesFDA applicant, unverified

Devices
11

What Sharpoint, Inc. makes

Sharpoint, Inc. manufactures single-use ophthalmic surgical instruments, including precision cutting tools like ear knives, corneal scleral lances, and various ophthalmic knives designed for eye procedures. Their portfolio also includes suture materials such as stainless steel sutures and silk surgical sutures, as well as specialized cystitomes for anterior and posterior capsulotomy. These devices are intended for use in cataract surgery and related ophthalmic interventions.

The company’s products are regulated under FDA classifications, with most devices falling into Class I or Class II categories. Authorisation records include submissions under 510(k) and PMA pathways, reflecting compliance with US medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Dacron R Surgical Sutures Ref K904263

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ear Knives Ref K840764

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Corneal Scleral Lance Ref K840855

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Coated Suture Needle Ref K863595

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Surgical Knife Ref K861947

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Anterior Capsulectomy Cystitome Ref K840659

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ophthalmic Knife Ref K822112

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Posterior Capsulotomy Cystitome Ref K840660

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Stainless Steel Suture 316l Ref K830522

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • V Lance Ref K821440

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silk Surgical Sutures Ref N85143

    Active Regimes: PMA Registry: PMA Class:II

Rows 1-11 of 11

Frequently asked questions

How many devices does Sharpoint, Inc. have in the registry?

The registry currently lists 11 devices for Sharpoint, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sharpoint, Inc.'s devices?

Among its 11 most recently registered devices, Sharpoint, Inc. has devices listed in FDA 510(k) (10 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Sharpoint, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Sharpoint, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Sharpoint, Inc. in the registry?

The most recently registered devices listed for Sharpoint, Inc. include DACRON R SURGICAL SUTURES, EAR KNIVES, CORNEAL SCLERAL LANCE and COATED SUTURE NEEDLE.

Generated automatically from registry data and not verified by a human reviewer.