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Innovative Surgical Products, Inc.

United StatesFDA applicant, unverified

Devices
12

What Innovative Surgical Products, Inc. makes

Innovative Surgical Products, Inc. manufactures single-use surgical devices for ophthalmic and thoracic procedures, including tubing sets for phacoemulsification and irrigation/aspiration systems, scleral globe plugs, vitrectomy handpieces, and pleural drainage reservoirs. Their portfolio also includes disposable surgical supports like headrests and lens insertion tools, as well as vacuum reservoirs and suction systems for fluid management in surgical settings.

The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is 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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  • Heslin Dispos. Tubing Set Ref K843041

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

  • Phacoemulsification Kits Ref K840695

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

  • Acuvac(Tm) Suction Reservoir 400cc And Ref K801350

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

  • Irrigation, Aspiration Tubing Sets Ref K841072

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

  • Disposable Scleral Globe Plug Ref K840693

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

  • Ispvac Tm Ref K802973

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

  • Disposable Tubing Sets Ref K820680

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

  • Lens Insertion Glide Ref K840694

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

  • Disposable Surgical Head Support Ref K801382

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

  • Disposable Irriga/Aspir. System Ref K821496

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

  • Pleural Drainage Reservoir Ref K820765

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

  • Disposable Vitrectomy Handpiece Ref K832235

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Innovative Surgical Products, Inc. have in the registry?

The registry currently lists 12 devices for Innovative Surgical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Innovative Surgical Products, Inc.'s devices?

Among its 12 most recently registered devices, Innovative Surgical Products, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Innovative Surgical Products, Inc.'s devices fall under?

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

What are the newest devices from Innovative Surgical Products, Inc. in the registry?

The most recently registered devices listed for Innovative Surgical Products, Inc. include HESLIN DISPOS. TUBING SET, PHACOEMULSIFICATION KITS, ACUVAC(TM) SUCTION RESERVOIR 400CC AND and IRRIGATION, ASPIRATION TUBING SETS.

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