BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR

• K Number: K033589
• Device Name: BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
• Manufacturer: MICROMEDICS, INC.
• Date Cleared: 2004-10-04 ( 326 days)
• Product Code: FMF
• Regulation Number: 880.5860
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The device is to be used for the Application of Tisseel® VH Fibrin Sealant.

Device Description

Baxter Duplotip Surgical Sealant Applicator

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Baxter Duplotip Surgical Sealant Applicator, a Piston Syringe. This document specifically addresses the regulatory clearance of the device based on substantial equivalence to a predicate device.

It does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on this document. This kind of detail is typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).