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Plasti-Pore Septal Button

by Richard'S Medical Equip., Inc.

510(k) K781574

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781574 Date27 Sep 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
FZE
Device Class
Class II
Regulation
21 CFR Part 878.3680
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 Plasti-Pore Septal Button is a prosthesis for the nose, internal, as defined in the device data. It is a device intended for use in general and plastic surgery applications.

The device received FDA 510(k) clearance under K781574 on September 27, 1978, and is classified as a Class II device with product code FZE. It is supplied non-sterile and is intended for reusable use, with no indication of sterility, single-use designation, MRI safety, specific sizes, or storage conditions provided in the data.

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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 Plasti-Pore Septal Button used for?

    The Plasti-Pore Septal Button is a prosthesis for the nose, internal, intended for use in general and plastic surgery applications as a nasal septal prosthesis.

  • Is the Plasti-Pore Septal Button supplied sterile or non-sterile?

    The device is supplied non-sterile, as indicated in the device data, and must be sterilized by the user prior to each use if required for the intended surgical application.

  • Is the Plasti-Pore Septal Button designed for single-use or reusable use?

    The Plasti-Pore Septal Button is intended for reusable use, meaning it can be cleaned, sterilized, and used multiple times following appropriate reprocessing protocols.

  • What regulatory pathway was used for the Plasti-Pore Septal Button?

    The device received FDA 510(k) clearance under K781574 on September 27, 1978, and was found substantially equivalent to a predicate device, which is the regulatory pathway for its market authorization.

  • What is the product code and device class for the Plasti-Pore Septal Button?

    The Plasti-Pore Septal Button is classified as a Class II device with product code FZE, as specified in the FDA 510(k) clearance documentation under regulation number 878.3680.