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Uniring Annuloplasty Ring With Sizers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071281

by Peters Surgical

Identifiers

510(k) Number
K071281 FDA 510(k)
FDA Product Code
KRH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3800 FDA 510(k)
Regulation Number
870.3800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Uniring is a flexible annuloplasty ring designed for surgical implantation in the mitral or tricuspid position to reinforce valve repair. The device functions as an annuloplasty ring and is provided with a holder assembly and a separate set of sizers to assist the surgeon in determining the appropriate annulus size.

This device is regulated under FDA 510(k) clearance. It is intended for use in a surgical setting to support cardiac valve repair procedures.

Frequently asked questions

What is the primary function of the Uniring?

The Uniring is a flexible annuloplasty ring designed for surgical implantation in either the mitral or tricuspid position. Its purpose is to provide structural reinforcement to the cardiac valve during repair procedures.

What components are included with the Uniring system?

The device is provided as a complete system that includes the flexible annuloplasty ring, a holder assembly for surgical handling, and a separate set of sizers. These sizers are used by the surgeon to accurately determine the appropriate annulus size required for the patient.

What is the regulatory status of the Uniring?

The Uniring is regulated under FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for use in cardiac valve repair.

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: UNIRING - ANNULOPLASTY RING WITH SIZERS (K071281) — FDA 510 (k ..., Uniring - Annuloplasty Ring With Sizers 510 (k) FDA Premarket ..., PDF AUGi 3 2007 - Food and Drug Administration, FDA 510 (k) Applications Submitted by PETERS SURGICAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Peters Surgical

Sources (1)

  • FDA 510(k) K071281 24 fields · synced Sep 27, 2026