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Terumo Surshield- Pur Safety I.v. Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100282

by Terumo Corp.

Identifiers

510(k) Number
K100282 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER is a safety intravenous catheter designed for short-term vascular access. It features a passive safety activation mechanism and SurFlash™ catheter placement indicator for visual confirmation of vessel entry. Constructed from polyurethane, the catheter is flexible, kink-resistant, and durable.

It is supplied for single-use insertion into the patient's vascular system to withdraw blood samples, administer intravenous fluids, or monitor blood pressure via an attached monitoring line. The needle shield feature helps prevent needlestick injuries. The device is authorized under FDA 510(k) clearance (K100282) with product code FOZ and was determined substantially equivalent to a predicate device.

Frequently asked questions

What is the TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER used for?

It is designed for short-term vascular access to withdraw blood samples, administer intravenous fluids, or monitor blood pressure via an attached monitoring line, featuring a passive safety mechanism to help prevent needlestick injuries.

Is the TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER reusable or single-use?

The device is supplied for single-use insertion into the patient's vascular system and is not intended for reuse, as stated in its description for safety and infection control reasons.

What material is the TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER made from, and what are its key features?

Constructed from polyurethane, the catheter is flexible, kink-resistant, and durable, and includes a SurFlash™ catheter placement indicator for visual confirmation of vessel entry and a passive needle shield to reduce needlestick risk.

How is the TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER supplied and what regulatory pathway was used?

It is supplied as a sterile, single-use device and received FDA 510(k) clearance (K100282) as substantially equivalent to a predicate device, with product code FOZ and classified under General Hospital advisory committee review.

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: Surshield-PUR Safety I.V. Catheters - terumotmp.com, PDF Front Cover Back Cover Surshield-PUR Safety I.V. Catheters Data sheet ..., Terumo Medical Corporation Surshield-PUR Safety I.V. Catheters 22G

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Terumo Corp.

Sources (1)

  • FDA 510(k) K100282 24 fields · synced Sep 24, 2026