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Spenco Medical Corp.

United StatesFDA applicant, unverified

Devices
10

What Spenco Medical Corp. makes

Spenco Medical Corp. manufactures wound care and skin protection products, including silicone gel sheets, sterile adhesive strips, hydrogel-based wound preps, and moist burn pads with aloe. Their portfolio also covers breast forms, dermal pads, skin guard kits, and cryopress devices designed for medical and post-operative skin management.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

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

Catalogue10

Newest first, rows 1-10 of 10

  • Gelskin Ref K791162

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

  • Spenco Silicone Gel Sheet Ref K981902

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

  • 2ND Skin Sterile Adhesive Strip Ref K922228

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

  • Spenco Breast Forms Ref K896533

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

  • Spencio Skin Guard Kit Ref K910927

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

  • Hydrogel-Prep Ref K791726

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

  • Spenco Dermal Pads Ref K811184

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

  • 2ND Skin Moist Burn Pads With Aloe Ref K911550

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

  • Spenco Cryopress Ref K820906

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

  • 2ND Skin Non-Stick Moist Burn Pads Ref K894898

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

Frequently asked questions

How many devices does Spenco Medical Corp. have in the registry?

The registry currently lists 10 devices for Spenco Medical Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Spenco Medical Corp.'s devices?

Among its 10 most recently registered devices, Spenco Medical Corp. has devices listed in FDA 510(k) (10 devices).

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

Among its 10 most recently registered devices, the classes recorded for Spenco Medical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Spenco Medical Corp. in the registry?

The most recently registered devices listed for Spenco Medical Corp. include GELSKIN, SPENCO SILICONE GEL SHEET, 2ND SKIN STERILE ADHESIVE STRIP and SPENCO BREAST FORMS.

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