DuploTip Surgical Sealant Applicator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K033589

Identifiers

510(k) Number: K033589 FDA 510(k)
FDA Product Code: FMF FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.5860 FDA 510(k)
Regulation Number: 880.5860 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The DuploTip Surgical Sealant Applicator is a single-use device classified as a fibrin sealant applicator. It is designed to deliver fibrin sealant, a biological adhesive used to promote hemostasis and tissue adhesion in surgical procedures, particularly in general hospital settings.

This applicator is supplied in rigid configurations with varying lengths (10 cm, 32 cm, and 40 cm) and a gauge of 5 mm. It is intended for single-use only and must not be used with the DuploSpray MIS system. The device holds FDA 510(k) clearance (K033589) and complies with the Medical Device Directive (MDD).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DuploTip Applicator with Snap Lock, 10cm - catalog.baxter.com, Product Catalog - Baxter, Product Catalog - Baxter, Product Catalog - Baxter, BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR (K033589) — FDA 510(k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K033589	Class II	Active

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Manufacturer

Manufacturer: Micromedics, Inc.

Sources (2)

FDA 510(k) K033589 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026