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Boston Pacific Medical, Inc.

United StatesFDA applicant, unverified

Devices
11

What Boston Pacific Medical, Inc. makes

Boston Pacific Medical, Inc. manufactures single-use medical devices for enteral and urinary care, including enema bags, feeding tubes, nasogastric and rectal tubes, suction catheters, and colostomy pouches. Their portfolio also covers anesthesia extension sets, oxygen cannulas, enteral feeding bags, female catheters, and urological procedure trays. These products are designed for clinical and home use in gastrointestinal, respiratory, and urinary applications.

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

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

Catalogue11

Newest first, rows 1-11 of 11

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  • 4 Sure Tm Enema Bag Set Ref K922398

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

  • 4-Sure Nelaton Catheter Ref K931048

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

  • 4 Sure Tm Feeding Tubes Ref K921853

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

  • 4 Sure Tm Anesthesia Extension Set Ref K924995

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

  • 4 Sure Tm Rectal Tube Ref K921852

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

  • 4 Sure Tm Nasal Oxygen Cannula Ref K922397

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

  • 4 Sure Tm Enteral Feeding Bag Ref K922402

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

  • 4-Sure Female Catheter Ref K931047

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

  • 4 Sure Tm Suction Catheters & Kits Ref K921851

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

  • 4 Sure Tm Colostomy Pouch Ref K922401

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

  • 4SURE Uro-Link Urological Procedure Trays Ref K933109

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Boston Pacific Medical, Inc. have in the registry?

The registry currently lists 11 devices for Boston Pacific Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Boston Pacific Medical, Inc.'s devices?

Among its 11 most recently registered devices, Boston Pacific Medical, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Boston Pacific Medical, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Boston Pacific Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Boston Pacific Medical, Inc. in the registry?

The most recently registered devices listed for Boston Pacific Medical, Inc. include 4 SURE TM ENEMA BAG SET, 4-SURE NELATON CATHETER, 4 SURE TM FEEDING TUBES and 4 SURE TM ANESTHESIA EXTENSION SET.

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