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Percuvance Percutaneous Surgical System

by Teleflexmedical, Inc. 2 variants

510(k) K153063

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153063 Date8 Apr 2016ClearedStatusActive

Recalls

9 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0754-2019 FDA Class II initiated 3 Jan 2018
    • Terminated Z-0753-2019 FDA Class II initiated 3 Jan 2018

    There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

    • Terminated Z-0059-2018 FDA Class II initiated 18 Oct 2017

    Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

  • 6 recalls, same reason

    • Terminated Z-3222-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3219-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3221-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3224-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3220-2017 FDA Class II initiated 19 Jul 2017
    • Terminated Z-3223-2017 FDA Class II initiated 19 Jul 2017

    For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Percuvance Percutaneous Surgical System is a percutaneous, micro-laparoscopic platform that enables minimally invasive surgery through a small incision site. It is designed to enter directly through the skin without an insertion trocar and can be attached to various tool tips for greater versatility in procedures. The system is intended for use in laparoscopic procedures, offering a reduced need for ports. The Percuvance System features a 2.9mm shaft that is percutaneously inserted using a Veress needle tip.

The Percuvance Percutaneous Surgical System is supplied with 5 mm tool tips and is designed for use in a variety of procedures. The system has received FDA 510K authorization and is classified under product code GEI. It is available in a single configuration, with a 2.9mm shaft size. The system is designed for percutaneous use and is intended to reduce trauma during laparoscopic procedures.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Percuvance System used for?

    The Percuvance System is used for laparoscopic procedures, offering a reduced need for ports and minimizing trauma.

  • How is the Percuvance System supplied?

    The system is supplied with 5mm tool tips and has a 2.9mm shaft size, available in a single configuration.

  • Is the Percuvance System designed for single-use or reuse?

    The device data does not specify whether the Percuvance System is designed for single-use or reuse, but it is intended for percutaneous use in laparoscopic procedures.

  • What is the regulatory status of the Percuvance System?

    The Percuvance System has received FDA 510K authorization, classified under product code GEI, and is considered substantially equivalent.