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ASPIRE BARIATRICS, INC.

US

Last updated May 24, 2026

What ASPIRE BARIATRICS, INC. makes

The company manufactures medical devices for managing gastric contents, including gravity-fed aspiration systems like stomach tubes and aspiration sets, as well as gastrostomy tubes for feeding or drainage. It also produces non-vascular catheter introduction sets, which assist in placing catheters for procedures like gastrostomy port installation. Kits and accessories, such as skin-port sleeves and tubing sets, are designed to support long-term use and maintenance of these systems.

These devices are regulated under FDA classifications, with most falling under Class II for moderate risk and some under Class III for higher-risk authorisation. They appear in the FDA’s 510(k) clearance registry for lower-risk devices and the PMA/Premarket Approval process for Class III products, alongside entries in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
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LinkedIn
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Facebook
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Phone
877-312-0007
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
026281163

Catalogue (56)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
AspireAssist Skin-Port-LANG A 200-0011-LANG A
FDA UDI
Class IIIActive
AspireAssist Skin-Port-LANG C 200-0011-LANG C
FDA UDI
Class IIIActive
AspireAssist First Year Kit, Magenta-LANG C 100-0037-LANG C
FDA UDI
Class IIIActive
Aspire Venting Tube K182248
FDA 510(k)
Class IIActive
Aspire Introducer Needle K180725
FDA 510(k)
Class IIActive
AspireAssist P150024
FDA PMA
Class IIIActive

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