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Suncoast Medical Manufacturers, Inc.

United StatesFDA applicant, unverified

Devices
31

What Suncoast Medical Manufacturers, Inc. makes

Suncoast Medical Manufacturers, Inc. produces surgical and ophthalmic electrosurgical devices, including reusable and disposable loop tips for tissue coagulation and cutting, flexible illuminators for enhanced visibility, and temperature-adjustable probes for controlled thermal applications. Their portfolio includes devices like the SURG-A-STAT loop tips, REPLACE-A-TIP rechargeable high-temperature probes, and OPTHERM fine and extra-fine tips designed for precision in surgical procedures. Illumination tools such as the SUN-LITE white spot and flexible illuminators are also part of their offerings, supporting visibility in delicate operations.

The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance for market authorisation. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance in the United States. The manufacturer operates from the US, adhering to domestic medical device regulations.

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

Catalogue31

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  • Sun-Lite White Slit Ref K840430

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

  • Surg-A-Stat Loop Tip 2 Ref K840387

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

  • Surg-A-Stat Loop Tip 15 Ref K840375

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

  • Replace-A-Tip Rechargeable High Temp Ref K841326

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

  • Flexible Illuminator 15 Ref K840372

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

  • Surg A Stat Fine Tip 5 Ref K840493

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

  • Sun-Lite White Spot Ref K841588

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

  • Optherm Extra Fine Tip Ref K840426

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

  • Surg-A-Stat Fine Tip Ref K840374

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

  • Adjust-A-Temp High Temperature Ref K841604

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

  • Flexible Illuminator 10 Ref K840373

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

  • Optherm Fine Tip Ref K840425

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

  • Sun-Lite One Millimeter Ref K840429

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

  • C-Lite Ref K841589

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

  • Replace-A-Tip Low Temp. Cautery Ref K840434

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

  • Replace-A-Tip Recharg. Low Temp. Ref K841325

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

  • Surg-A-Stat Cardiovascular Tip Ref K840377

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

  • Surg-A Stat Loop Tip Ref K840376

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

  • Replace-A-Tip Adjustable High Temp. Ref K841509

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

  • Sun-Lite Blue Slit Ref K840492

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

  • Sun-Lite Pen Light Ref K840428

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

  • Surg-A-Stat Vasectomy Tip Ref K840370

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

  • Adjust-A-Temp Extra Fine Tip Ref K840378

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

  • Adjust-A-Temp Micro Ref K841603

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

  • Sun-Lite 1 Ref K840456

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

  • Flexible Illuminator 5 Ref K840371

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

  • Surg-A-Stat Fine Tip 2 Ref K840585

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

  • Replace-A-Tip High Temp. Cautery Ref K840433

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

  • Pyro-Tip Ref K841591

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

  • Replace-A-Tip Adjust. Low Temp.- Ref K841459

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

  • Sun-Lite Blue Spot Ref K840427

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

Rows 1-31 of 31

Frequently asked questions

How many devices does Suncoast Medical Manufacturers, Inc. have in the registry?

The registry currently lists 31 devices for Suncoast Medical Manufacturers, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Suncoast Medical Manufacturers, Inc.'s devices?

Among its 31 most recently registered devices, Suncoast Medical Manufacturers, Inc. has devices listed in FDA 510(k) (31 devices).

What risk classes do Suncoast Medical Manufacturers, Inc.'s devices fall under?

Among its 31 most recently registered devices, the classes recorded for Suncoast Medical Manufacturers, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Suncoast Medical Manufacturers, Inc. in the registry?

The most recently registered devices listed for Suncoast Medical Manufacturers, Inc. include SUN-LITE WHITE SLIT, SURG-A-STAT LOOP TIP 2, SURG-A-STAT LOOP TIP 15 and REPLACE-A-TIP RECHARGEABLE HIGH TEMP.

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