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Lukens Corp.

United StatesFDA applicant, unverified

Devices
12

What Lukens Corp. makes

Lukens Corp. manufactures sterile surgical and procedural supplies, including catheterization trays with Foley catheters, irrigation trays, shave prep sets, and skin scrub prep sets. Their portfolio also covers single-use surgical blades and handles, bone wax treated with gamma radiation, sterile lap sponges, suture removal kits, and silk sutures.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with some products authorised via 510(k) and others through PMA pathways. Their products are listed in the FDA’s regulatory databases and are based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

Newest first, rows 1-12 of 12

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  • Sixalyzer Ref K880230

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

  • Tray, Catheterization W/Foley, Sterile Ref K770797

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

  • Shave Prep Set Ref K770795

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

  • Tray, Irrigation, Sterile, Basic Ref K770799

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

  • Handles, Blade, Surgical Ref K770800

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

  • Lukens Bone Wax (Gamma Radiation) Ref K791495

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

  • Blades, Surgical, Sterile Ref K770798

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

  • Skin Scrub Prep Set Ref K770796

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

  • Stanford Sterile Lap Sponges Ref K800102

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

  • Suture Removal Set, Sterile Ref K770794

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

  • Stanford Sterile Lap Sponges Ref K792471

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

  • Silk Sutures Ref N80989

    Active Regimes: PMA Registry: PMA Class:II

Rows 1-12 of 12

Frequently asked questions

How many devices does Lukens Corp. have in the registry?

The registry currently lists 12 devices for Lukens Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lukens Corp.'s devices?

Among its 12 most recently registered devices, Lukens Corp. has devices listed in FDA 510(k) (11 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Lukens Corp.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Lukens Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Lukens Corp. in the registry?

The most recently registered devices listed for Lukens Corp. include SIXALYZER, TRAY, CATHETERIZATION W/FOLEY, STERILE, SHAVE PREP SET and TRAY, IRRIGATION, STERILE, BASIC.

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