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Surgicot, Inc.

United StatesFDA applicant, unverified

Devices
19

What Surgicot, Inc. makes

Surgicot, Inc. manufactures single-use medical accessories and protective barriers, including universal mouthpieces, ventilator adaptors, peel-open pouches, and sterile packaging systems like the Surgipeel and Pro-Guard wraps. Their portfolio also covers specialized tubing (corrugated #770 & #771), aerosol adapters (#752), and surgical tools such as the Eye Spear and Neuro Sponge. Additional products include biological/chemical indicators (ASSERT), breathable pouches, and wound care items like the Band-Aid Ice-Bandage. Steam test packs and corrugated tubing are designed for procedural and sterilization validation.

The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance. The manufacturer is based in the United States.

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

Catalogue19

Newest first, rows 1-19 of 19

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  • Universal Mouthpiece, #750 Ref K770586

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

  • Surgicot Steam Test Pack Ref K854902 Open recall

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

  • Ventilator Adaptor, #751 Ref K770587

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

  • Surgipeel Self-Seal Packaging System Ref K820302

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

  • Corrugated Tubing #770 & 771 Ref K770593

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

  • Aerosol T Adapter, #752 Ref K770585

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

  • Pouches, Peel Open, Breathable Ref K771032

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

  • Eye Spear Ref K840471

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

  • Assert Tm Biological/Chemical Indicator Ref K855101

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

  • Neuro Sponge Ref K840541

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

  • Band-Age Ice-Bandage Ref K761254

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

  • Pro-Guard Double-Duty Sterilization Wrap (Single Use) Ref K962605

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

  • Suogipeel Packaging System Ref K771846

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

  • Pro-Guard Ref K830739

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

  • Surgiscribe Marking Pen Ref K840470

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

  • Assert Eo Biological Test Pack Ref K854631

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

  • Surgicot 2 Indicator System Ref K800029

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

  • Surgiclean Enzymatic Instrument Cleaner Ref K931270

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

  • Assert Biological/Chemical Indicator 12 Month Exp. Ref K863122

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

Rows 1-19 of 19

Frequently asked questions

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

The registry currently lists 19 devices for Surgicot, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Surgicot, Inc.'s devices?

Among its 19 most recently registered devices, Surgicot, Inc. has devices listed in FDA 510(k) (19 devices).

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

Among its 19 most recently registered devices, the classes recorded for Surgicot, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Surgicot, Inc. include UNIVERSAL MOUTHPIECE, #750, SURGICOT STEAM TEST PACK, VENTILATOR ADAPTOR, #751 and SURGIPEEL SELF-SEAL PACKAGING SYSTEM.

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